"FDA label" tab
Quick start
This tab enables you to generate a customizable consumer product label that includes a US Food and Drug Administration (FDA) "Drug Facts" label. The "Drug Facts" label is typically in a box or panel affixed to the "immediate" product container. It also appears on an outer package, if any, that the consumer first encounters when purchasing the product. It's on the back of an antiseptic mouthwash bottle and on the side panel of a box of aspirin.
The FDA requires Drug Facts for over-the-counter (OTC) drug and drug-cosmetic products. Drug Facts are not required for purely cosmetic products.
The consumer product label draws from information you enter on this tab, plus the supplier logo from the "1 Identification" tab and ingredient information from the "3 Composition" tab.
This product label is not part of a safety data sheet and is not a GHS label. However, there are occasions where you might want to generate consumer labels for a product that also requires a safety data sheet and GHS labels for importers, distributors, retailers, and other businesses.
CAUTION: Preparing a label including the FDA Drug Facts requires some familiarity with FDA regulations for over-the-counter (OTC) drug and drug-cosmetic products. You will need to know your product's characteristics as they relate to the FDA requirements. Links to some of the regulations appear below.
Steps
1. Verify that the ingredients are listed in the Component table
If you have SDScribe™ automatic help turned on, click to turn it off, so that this help window won't update when you change to another tab on the SDS entry form.
Turn auto-help on and off from this window.
a) Navigate to the "3 Composition" tab.
b) Ensure all product ingredients are listed as components, in the Component table.
i) Add any components that are missing.
You must enter a chemical name (or, initially, an identification number like a CAS number) in the "Name (enter CAS, EC, or name)" column to save a component in the table; the column cannot be empty.
ii) Arrange the components in reverse order of predominance: the component with the highest content/concentration is the first one listed.
Use the up and down arrows on the left of the table, to move highlighted rows individually up or down.
c) For convenience in viewing the FDA-specific columns of the table, set the Column view to "FDA".
Component table on Tab "3 Composition"
d) If the chemical name in the "Name (enter CAS, EC, or name)" column is different from the FDA established name (to be used in the Drug Facts box), then enter the established name into the "FDA name" column.
How the program selects a component name for the Drug Facts box…
The Drug Facts box includes the names of most ingredients. The program selects the ingredient name to be used based upon availability:
1. The "FDA name" column, or for non-English labels, an "FDA name (click translate)", takes priority.
o This name is the FDA “established name” for an ingredient (refer to the discussion of Automatic “FDA name” insertion, immediately below.)
o The "FDA name" column lets you specify unequivocally what ingredient name the program will use when building the Drug Facts box.
2. Without an FDA name, the program will use the "Alternative/generic name" column, or for non-English labels, the "Alternative/generic name (click translate)".
3. Without an FDA name and without an alternative/generic name, the program will use the "Name (enter CAS, EC, or name)" column, or for non-English labels, the "Name (click translate)".
Automatic "FDA name" insertion in the Component table
When you add a component or update† an existing component in the table, the program will insert a name into the "FDA name" column automatically. It does so by looking for synonyms for the component (Substances section, "Identification" tab, Synonym table), in the following order of synonym type:
o FDA 701.30 name (for specific chemicals)
o Common name
o Where none of these synonyms are available: Chemical name
If you determine that the "FDA name" the program has inserted is incorrect, you should replace it by manually entering a more suitable component name into the cell.
†Updating a highlighted row in the Component table.
2. Designate active and inactive ingredients in the Component table
Active ingredients
Active ingredients are those components that are:
"…intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect (21 CFR 201.66(b)(2)).
· Examples include analgesics (pain relievers), antiseptics, expectorants, and sunscreens.
· Strictly cosmetic effects do not qualify an ingredient to be active.
Active ingredient order in the Drug Facts box
If there are multiple active ingredients, the program will automatically list them alphabetically in the Drug Facts box. However, you should not place them in alphabetical order in the Component table.
a) In the table, designate a component as an active ingredient by selecting a purpose, in the "FDA actv purpose" column.
i) Select a purpose from the drop-down list, or enter it directly into the cell.
If you are unsure of what purpose to use, you can perform an FDA active ingredient search[1] or a SpecialChem search for products containing (or that represent) the ingredient.
ii) For a non-English label, enter the translated purpose in the language you plan to use, in the "FDA actv purpose (click translate)" column.
To display a translation dialog for converting the contents of the English-language "FDA actv purpose" column to another language, click on the "FDA actv purpose (click translate)" column header.
b) In the "FDA potency" column, enter the potency (concentration/strength) of the active ingredient.
i) For products taken orally by the dose, use units of measure that are relevant to the dose units.
As an example, suppose that the recommended dose for an acetaminophen-containing cough syrup is two 5-ml teaspoonfuls every four hours, and the potency of the ingredient in the product is 160 mg per 5-ml teaspoonful.
If you enter "160 mg" in the "FDA potency" column, acetaminophen will appear in the active ingredients list as "Acetaminophen 160 mg".
Later, on the "FDA label" tab, you will enter a suffix for the "Active ingredients" title: "5-ml teaspoonful". This suffix will cause the title to become "Active ingredients (in each 5-ml teaspoonful)".
ii) For products like topical ointments that have a recommended dose, the potency should be in grams per gram of product.
iii) For products like topical ointments or therapeutic shampoos that have no recommended dose, use the proportion of the ingredient in the product mixture. As an example, a lip balm might contain "White petrolatum 38.5%" and "Avobenzone 2.5%" as active ingredients.
iv) You can copy over the SDS concentrations from the "Min %" and "Max %" columns by highlighting the ingredient row(s) and clicking on the "FDA potency" column header. Care should be taken with this approach, however, because the SDS concentrations are typically an outer range of values, whereas the FDA potency should be a single concentration value.
v) In some cases it may be necessary to indicate an active portion of the ingredient. For example, for the ingredient "Coal tar solution" as in a shampoo, you might use "Coal tar solution 1.5% (coal tar 0.5%)". You can obtain information of this type from an FDA active ingredient search on coal tar, to review the labels on products similar to yours.
Component table, entering active ingredients.
Inactive ingredients
Inactive ingredients do not have physiological/health effects on the body.
§ Examples are colors, flavorings, fragrances, preservatives, sweeteners, tablet binders/fillers, and ingredients with purely cosmetic effects.
Inactive ingredient order in the Drug Facts box
§ By default, the program lists inactive ingredients in the order that you set in the Component table, which should be by reverse order of predominance. This order is appropriate for a combination drug-cosmetic product.
§ Exceptions to the inactive ingredient list order:
o Components at 1 percent or lower concentration can appear in any order, as long as they are below the other components present at higher levels. The program automatically lists 1-percent components in their order of appearance in the Component table.
o Color additives appear after the other listed components, and can be in any order within the other color additives. The program automatically lists them in their order of appearance in the Component table.
o A component or components for which the FDA has approved for your organization to withhold the name as a trade secret will appear automatically as a final statement, "…and other ingredients".
o If you have an OTC drug-only product (no cosmetic effects), the inactive ingredients must sort alphabetically. This exception does not happen automatically; you will have the option to specify alphabetical order in a label generation options dialog, just before the program generates the label.
Component table, entering inactive ingredients.
For inactive ingredients in the Component table:
c) Ensure that the "FDA actv purpose", "FDA actv purpose (click translate)", and "FDA potency" columns are empty.
d) Check the box in the "FDA may contain" column for inactive ingredients that you may occasionally substitute with other ingredient(s) in the product formula. You might substitute one ingredient for another because of availability or supply constraints. In the generated Drug Facts label, the program will append an asterisk to the ingredient name, and add a note at the bottom to indicate that:
i) "* may contain this ingredient"; OR
ii) "* contains one or more of these ingredients"
e) For inactive ingredients that are color additives, check the box in the "FDA color" column.
i) Designation as a color additive allows the program to place the ingredient in Drug Facts below the ingredients that are listed in reverse order of predominance.
f) For inactive ingredients that you have claimed as confidential (trade secrets), check the box in the "FDA w/h" column.
i) Confidential ingredients do not appear as individual items in Drug Facts. Instead, they appear collectively in one statement at the end of the inactive ingredient list: "…and other ingredients".
ii) You must obtain approval by submitting a claim to the FDA.
g) For inactive ingredients that are fragrances and/or flavors, you can enter them generically in the "FDA name" column so that the actual chemical names won't appear in the Drug Facts box.
i) Examples: "Fragrance", "Flavor", or "Flavor and fragrance"
ii) Place each ingredient of these types in reverse order of predominance in the Component table, along with the other ingredients.
h) For inactive ingredients that are incidental to product manufacturing, enter the word "incidental" into the FDA name column to prevent them from being included in the inactive ingredient list.
i) Incidental ingredients in a cosmetic product are present at insignificant levels and have no technical or functional effect in the cosmetic.
ii) Examples can be processing aids (filter aids, defoaming agents, etc.), raw materials that after processing become listed ingredients in the final product, and raw material preservatives that remain at insignificant levels in the final product.
3. Select the language for a non-English label (optional)
a) If you plan to generate only an English-language label, you can skip this step.
b) Select the non-English language using the drop-down menu at upper right on the entry form.
c) Choose a language other than English.
d) If you select a language from the menu that does not have an asterisk (*) following the language name, then the program does not yet fully support it, and portions of the label may default to English.
e) Ensure that you have entered information in the desired non-English language, into the non-English fields.
i) Click on the "NE lang" button at the bottom of the SDS entry form, to view all non-English fields on the "FDA label" tab and its sub-tabs.
Language selection menu, SDS entry form.
4. Enter information on the "Label Content 1" and "Label Content 2" sub-tabs.
About text entry and bullet shortcuts
"Label content 1" sub-tab (for items that should appear above the FDA Drug Facts box)
Items above the Drug Facts box
· These items represent typical text and graphics for a consumer label. If you leave some of the items empty, the program will skip those items on the label.
a) Name (top left on the SDS form, above the sub-tabs) — This item is the name of the product itself, which appears at top left on each SDS tab.
i) No entry should be necessary here, since your product should already have a name.
ii) Changing the product name will affect other areas of the program, such as product names in the Substance and Batch sections, and SDS form and GHS label generation.
b) Logo (product logo, graphic field) — Copy a product logo to the clipboard from the Windows desktop or from another application, and then right click to paste it into the field.
i) For logos larger than the field area, not all of the logo may be visible on the entry form. However, it should still appear in its entirety on the label.
ii) Right click and select "Clear" to remove a logo from the field. (In this case, the logo won't appear on the generated label.)
iii) You can scale or omit the product logo in a dialog, prior to generating the label.
c) Description — Enter product characteristics, qualities, etc.
d) Warnings in red — Warnings about the product use that you want to emphasize, if any. Most likely these items would also appear in the Warnings section of the Drug Facts box. Display on the label in red text.
e) Supplier logo (graphic field) — The program obtains the supplier logo from Tab "1 Identification". If nothing is there, the program will also search for a logo in Preferences.
i) You can scale or omit the supplier logo in a dialog, prior to generating the label.
f) Size/amount — The amount of product in the consumer package (net weight, volume, number of tablets, etc.)
g) TAMPER EVIDENT: … — A statement of how the contents are protected and how to detect a breach. Example: "Do not use if imprinted inner safety seal is torn or missing."
i) This statement appears in a separate box, above the Drug Facts box.
h) NDC number — Enter a National Drug Code number if your product has one.
"Label content 1" sub-tab (for items that should appear within Drug Facts box)
Items inside the Drug Facts box
· The contents of the Drug Facts box are specified in FDA regulations (21 CFR 201.66).
· The Drug facts box cannot contain commercial graphics or commercial information.
· Section titles within the Drug Facts box won't appear on the label, unless you enter text into the section. Exceptions are "Drug Facts", "Active ingredient(s)", "Use(s)", "Warnings", and "Directions", which must always appear.
· An ellipsis ("…") following a section title means that the program will insert the preceding text in boldface, as a prefix to the text that you enter in that section.
a) Active ingredient(s) (in each ____) — Enter the dose unit (e.g., "tablet", "5 ml teaspoonful", "heaping tablespoonful", "gram", etc.). For products that do not have a dose, leave this item empty.
b) Use(s) — Indicate the specific indications or approved use(s) for the product. Do not include cosmetic indications/uses.
c) Warnings (subject-specific) — Include subject-specific warnings for particular circumstances and/or for products containing specified ingredients.
i) Examples: "For external use only", "Asthma alert:", "Choking:", etc.
ii) Consult the regulations (21 CFR 201.66(c)(5) for applicable circumstances, specific language, and/or formatting that may be needed.
d) Do not use… — Identify circumstances under which the consumer should avoid using the product.
i) Examples: "On children less than 2 months of age"; "On open skin wounds"
ii) The program will prefix text you enter with the section title in boldface. Examples:
· For a single item, "Do not use on children less than 2 months of age."
· For two items, using square bullets, "Do not use ■ on children less than 2 months of age ■ on open skin wounds"
e) Ask a doctor before use if you have… — Include warnings for patients who have preexisting conditions (excluding pregnancy) or who experience certain symptoms.
i) Example: "Ask a doctor before use if you have deep wounds or serious burns"
f) Ask a doctor or pharmacist before use if you are… — Include drug-drug and drug-food interaction warnings.
g) When using this product… — Include side effects that the customer may experience. Also include substances or activities that should be avoided while using the product.
h) Stop use and ask a doctor if… — Identify signs of toxicity or other reactions indicating that the user should immediately stop using the product.
i) For drug products with no toll-free number on the packaging for reporting side effects, this section should include the following text:
"[Bullet] side effects occur. You may report side effects to FDA at 1-800-FDA-1088."
j) Other required warnings — Use this area for warnings that appear (1) in the relevant OTC drug monograph[2] for the drug class; (2) that are in OTC drug regulations; or (3) in an approved drug application; and which do not fit into any of the previously listed warning categories.
"Label content 2" sub-tab (for items that should appear within the Drug Facts box)
a) If pregnant or breast-feeding… — Include "ask a health professional before use" for most OTC drug products intended for systemic absorption. Consult FDA regulations at 21 CFR 201.63 for exceptions and additional requirements.
b) Keep out of reach of children. — The program automatically inserts this phrase whenever you enter any (other) text into this section (i.e., when the section is not blank).
c) For oral drugs, include the following: "In case of overdose, get medical help or contact a Poison Control Center right away"
d) For topical drugs, include the following: "If swallowed, get medical help or contact a Poison Control Center right away"
e) Other circumstances may require additional phrases. Refer to 21 CFR 330.1(g)
f) Directions — Instructions for use of the product. You can use bulleted statements, a table, or a combination of the two. If you are providing dosage directions for three or more age groups or populations, you should use a table.
i) At present, the program does not create tables. However, you can simulate a table using shorthand characters for drawing horizontal lines ("\line") and tabs ("\t").
ii) For example, entering this text into the Directions section:
Directions box, illustrating the user of shorthand characters for drawing a horizontal line ("\line") and a tab ("\t") between the age group and the dosage level.
… results in a label containing formatted directions, with light gray lines separating the age groups/dosages:
Simulating a dosage table by age group. There are four gray lines separating the three age group-dose ranges.
g) Other information — Enter in this section items not included under the other headings.
i) This information might come from an OTC drug monograph, a regulation, or an approved drug application.
ii) Some ingredients above threshold levels and in particular routes of administration may require notifications in this location. Examples include sodium, calcium, magnesium, potassium, and phenylalanine/aspartame. Where present, these items should appear before other items of information.
iii) These items can be bulleted.
iv) Refer to more detailed requirements at 21 CFR 201.66(c)(7).
h) Questions? — Provide a phone number or other means of contact to answer questions about the product.
i) You may want to provide a separate number for Spanish speakers (or, if relevant, some other non-English language selected for the label).
ii) If feasible, include the days and times where a person is available to respond to questions.
"Label content 2" sub-tab (for items that should appear below the Drug Facts box)
a) Distributed by — Enter the name of the distributor.
i) The first line should be something similar to "Distributed by:" or "Distributed and marketed by:", etc.
ii) You can also click on the "Distributed by" button to copy the address from Tab "1 Identification"; from Preferences; or from the Suppliers section of the program.
b) Made in — Specify the country of origin for the product.
c) Other information — Include any information that you would like to convey below the FDA Drug Facts box, like "Satisfaction guaranteed", etc.
d) Product no. — This is the same number/code as used on Tab "1 Identification". You should not need to enter it again.
e) Lot no. — Manufacturing lot number.
f) Use before — Last fresh use date.
5. Label button
a) Click on the Label button at the bottom of the form ("Build" controls).
You can access the Label button from any SDS entry form tab.
In the lower ("FDA labels") section of the button menu, select either the "EN – English*" or the other (non-English) label option.
i) The other (non-English) option that appears in the button menu will depend on the language you selected earlier.
ii) If you accidentally select an item from the upper menu section, then the program will present options for generating a GHS label, rather than an FDA Drug Facts label. Cancel and try selecting again.
Selecting an FDA-type label to generate, from the Label button menu.
6. Overwrite existing content
a) If text or graphics content is already present in the word processing area where the newly-generated label will appear, the program will ask you to confirm replacement of the existing content.
Replacing existing content will clear only the word processing area where the generated label appears. It will not remove any information you have entered on other SDS entry form tabs.
Click on the Continue button to proceed.
If you do not see this confirmation request, skip to the next step.
Confirmation to overwrite existing content in the word processing area.
7. Select label generation options
a) The program presents a dialog containing a variety of options for customizing both the content and the appearance of the generated label.
As long as you save the SDS record following label generation, the program will remember your selections.
For a description of the options, refer to Label generation options, below.
"Select label generation options" dialog.
8. Generate the label
Click on the OK button on the "Select label generation options" dialog, to generate the label. It will appear in the word processing area.
9. Save your work
a) Click on the [S]ave button (disk icon, lower right) or the Done button on the SDS entry form, to save the SDS record. The generated label is part of the SDS record, so saving the SDS record also saves the generated label.
If you instead click on the Cancel button, then the generated label won't be preserved; nor will any SDS revisions or other entries you have made since you last saved the SDS record.
Save, Done, and Cancel buttons.
10. Print the label
The word processing area has its own menu bar. From that menu bar, select "File -> Print" or "File -> Print Preview". If your computer has a Portable Document Format (PDF) print driver installed, you can generate a PDF directly using the "File -> Print" command.
Print the label (from the word processing area menu bar).
11. Save copy to disk (Optional)
a) You can save a copy of the label to a separate file on disk, by selecting "File -> Save as…" from the word processing area's menu bar. Save in the native format (".4w7") or in a Microsoft® Word-compatible format (".doc" or ".rtf").
Label graphics (e.g., company logo, NFPA diamond) may lose some of their original sharpness when printed from an external word processing program. For best results, print directly from the word processing area.
Save label to an external file on disk.
Managing help
· If this help window opened automatically when you started the program, then you have automatic help turned on. To change automatic help, click on the “Auto-help is” on/off pushbutton, on this window.
· When automatic help is off, you can display or refresh this help window manually, by using the [Ctrl]-9 shortcut (“Background for this section”).[3]
· To get an overview:
o Take the Brief tour on how the SDS entry form works:
§ Entering SDS content
§ Navigating the form
§ Shortcuts and convenience features
§ Translation features
§ Generating the SDS and GHS labels
§ To start the tour, click on the Help button and select “Brief tour”.
o Watch the video on this tab (click on the Video button, if the label is in blue text).
o Navigate to Tab "1 Identification" and view or refresh the background help. Read the section, “Features common to most SDS form sections/tabs”.
· For brief tips, hover with your mouse over the object of interest.
· There is not as yet any guide window content for the “FDA label” tab.
· To learn additional details, read the information immediately below.
"FDA Label" tab — details
Contents
Title: "Drug Facts" or "Drug Facts (continued)"
Purpose(s) (for each active ingredient)
"Questions" or "Questions or comments?"
Text entry (general information)
Place company logo below Drug Facts box (normally above)
Alphabetize inactive ingredients
Scaling: Product logo and Company logo
General
Sample program-generated FDA label (partial), shown in the word processing area on the "FDA label" tab, "Build label English" sub-tab. In this example, the user changed the style of the product name, for a custom look.
· The "FDA label" tab on the SDS form generates a label that includes both general product information and an FDA-type Drug Facts information box.
o The Drug Facts box follows a format specified by the US Food and Drug Administration.
· There are four sub-tabs on the "FDA label" tab: two containing data entry areas and two with word processing areas.
o The "Label content 1" and "Label Content 2" sub-tabs supply most of the information for the generated label.
o Depending on the selected language, the generated label appears in a word processing area on one of the two other sub-tabs: "Build label English" or "Build label non-English".
o Additional information for the label comes from the "1 Identification" tab (the supplier logo), and from the "3 Composition" tab (ingredients).
Drug Facts information
The Drug Facts portion of the label applies to drug and drug-cosmetic products sold "over-the-counter" (OTC) in the United States. The defining law is the Federal Food, Drug, and Cosmetic Act, and the regulations are available at 21 CFR Section 201.66. An FDA guidance document is also available, which explains the requirements in additional detail and includes recommendations. Depending on your product ingredients and its application, however, it may be necessary to consult the full regulations. Some circumstances require specific language, placement, and formatting of warnings.
Placement and general content
· The Drug Facts information should appear on the outside container or wrapper or (if there is no outside container or wrapper) on the "immediate" container label.
· It has borders, forming a box with separations between sections.
· The Drug Facts box should not include product brand names, advertising, graphic images, or UPC labels. You can, however, indent the lower-right corner of the box to place a UPC label adjacent to the box.
Sample Drug Facts label (FDA).
Drug Facts sections
These comments apply generally to an FDA Drug Facts box, not specifically to the SDScribe™ implementation. For more complete requirements, you may want to read the FDA guidance document and/or consult the full regulations.
Title: "Drug Facts" or "Drug Facts (continued)"
"Drug Facts" should appear at the top of the panel. If there is more than one panel, then the "Drug Facts (continued)" title should appear at the top of each subsequent panel.
Active ingredient(s)
· These are the product components with health-related functionality, such as diagnostic capabilities, disease prevention, treatment, etc.
· Ingredients that have exclusively cosmetic effects should not be listed as active ingredients.
· Each active ingredient should include potency in dosage units or concentration.
o For oral-dose OTC drugs: Use the same dosage unit that appears in the Directions section (e.g., "per tablet", as in "Fexofenadine HCL USP, 180 mg per tablet")
o For topical products with dosages: Use the amount of active ingredient per gram of product (e.g., "Bacitracin, 400 units per gram")
o For topical products without dosages:
§ Use the percent of the active ingredient (e.g., "1%")
§ In some cases available concentration may also be required: e.g., "Sodium fluoride 0.24% (0.14% W/V fluoride ion)". This information should be available in the OTC drug monograph for the active ingredient.
· In cases of more than one active ingredient, they should be listed in alphabetical order.
Purpose(s) (for each active ingredient)
Each active ingredient should include its general pharmacological category/categories or principal intended actions (e.g., "Expectorant", "Sunscreen").
Use(s)
· Include the drug-related indications for product usage.
· In a combined drug-cosmetic product, only the drug-related uses should be included, not the cosmetic uses.
Warning(s)
Subject-specific warnings
· These warnings are required for particular circumstances and/or for products containing specified ingredients.
o Consult the regulations for the applicable circumstances, specific language, and/or formatting that may be needed.
· Warnings about Reye's syndrome (for drug products containing salicylates) should appear first.
o "Reye's syndrome: …" (followed by specific Reye's warning)
· List other subject-specific warnings in order of importance/impact. Samples:
o "For external use only" (for topical products)
o "For rectal use only"
o "For vaginal use only"
o "Allergy alert: …" (followed by specific warning)
o "Asthma alert: …" (followed by specific warning)
o Flammability using the correct "signal" words (e.g., "Extremely flammable", "Flammable", "Combustible")
o "Choking: …" (followed by specific warning)
o "Liver warning: …" (followed by specific warning)
o "Stomach bleeding warning: …" (followed by specific warning)
o "Sore throat warning: …" (followed by specific warning)
o "Dosage warning: …" (followed by specific warning regarding sodium phosphates)
o "Sexually transmitted diseases (STDs) alert: …" (followed by a warning regarding nonoxynol 9-containing spermicides and vaginal contraceptives)
Subcategory warnings
Certain warnings fit into subcategories, where in most cases the subcategory title precedes the warning(s), in boldfaced text:
o Do not use… (absolute contraindications for use)
o Ask a doctor before use if you have… (for persons with certain preexisting conditions or who experience certain symptoms)
o Ask a doctor or pharmacist before use if you are… (for drug-drug and drug-food interaction warnings)
o When using this product… (for side effects the person may experience, and the substances or activities to avoid)
o Stop use and ask a doctor if… (for signs of toxicity or other reactions necessitating immediate discontinuation of use)
§ If the package does not include a toll-free number for complaints, include the following statement:
‘‘• Side effects occur. You may report side effects to FDA at 1–800– FDA–1088."
o Required warnings (no prefix) — Warnings that appear in a relevant OTC drug monograph, other drug regulations, or a drug application; but which do not fit into one of the other subcategories.
o Pregnancy and pregnancy-related
o Keep out of reach of children (including accidental overdose/ingestion)
Directions
· Can be a table and/or bulleted statements
· A table format should be used if dosage directions are different for three or more age groups/populations.
Other information
· For items not included under the other headings
· The presence of sodium, calcium, magnesium, and potassium above specified levels triggers notification requirements. Refer to 21 CFR 201.64, 201.70, 201.71, and 201.72, respectively.
· Where relevant, this section must include a standard warning for phenylalanine/aspartame content:
o "Phenylketonurics: Contains Phenylalanine (insert quantity) mg per (insert appropriate dosage unit)."
· Tamper-evident packaging
o Informs consumers how to detect if the packaging has been opened or if a protective seal is entirely missing.
o When present within the Drug Facts box, this warning must appear under "Other information".
o This warning can also appear in a separate location outside of the Drug Facts box.[4] The FDA recommends the separate location approach when the warning would not otherwise be readily visible before the consumer opens the outside packaging.
· Storage conditions, such as temperature and moisture
Inactive ingredients
· Inactive ingredients are any components of the product other than active ingredients.
· For drug products that are not also cosmetics, these items should be listed in alphabetical order.
· For drug-cosmetic products, the inactive ingredients should be listed in descending order of content in the product.
· Where specific inactive ingredients vary due to supplier constraints, this section can contain a statement referring to specific ingredients, e.g., "* contains one or more of these ingredients", where the variable ingredients have a similar notation.
"Questions" or "Questions or comments?"
· When this heading is included in the Drug Facts box, a telephone number or other source of information should be included.
· The FDA recommends including days of the week and times of availability for a person to respond to calls, etc.
SDScribe™ implementation
Text entry (general information)
· Text entry areas (label sections) on the sub-tabs are numbered in the approximate order of their appearance on the generated label.
· Section titles won't appear on the label if you don't enter any text.
o Exceptions are the titles "Drug Facts", "Active ingredient(s)", "Use(s)", "Warnings", and "Directions", which appear even on otherwise empty labels.
· Section titles in italics on the entry form indicate that the content is entered in other locations on the SDS entry form (not on the "Label content 1" or "Label content 2" sub-tabs).
· Entry areas with section titles ending in an ellipsis ("…") will insert that title in boldface text, as a prefix to the text you enter.
o For example, if you enter "if you are driving a vehicle" in the "10. Do not use…" box, the generated label will include the expression "Do not use if you are driving a vehicle".
· Bullet shortcuts and other replacement actions — You can use shortcuts to produce bullet-type characters in the generated label:
o An asterisk (*) will become a square bullet.
o Closed empty square brackets ("[]") will become a small square bullet.
o Closed empty parentheses ("()") will become a round bullet.
o Closed empty curly brackets ("{}") will become a diamond/lozenge-type bullet.
o A cross sign/dagger ("†", Windows alt code "0134") will become an asterisk.
o As an example, if you enter "() if you are driving a vehicle" in the "10 Do not use…" box, the generated label will include the expression "Do not use • if you are driving a vehicle"
· To enter other special characters, use the Windows alt codes, or display the Windows Character map (Start menu -> enter "Character map" in the search box).
· For non-English product labels, you can enter information by:
o Viewing or enlarging non-English fields individually, by clicking on the zoom button (magnifying glass icon) to the right of the equivalent English field (select "Show non-English" or "Zoom non-English").
o Viewing all non-English fields on the tab at once, by clicking on the NE lang button at the bottom of the form ("Edit" controls).
o Entering information into an English-language field, and then using the translation dialog for assistance in converting the information into the non-English language fields. Select "Translate" from the "zoom" button menu.
The "zoom" button to the right of the field (magnifying glass icon) displays a pop-up menu.
You can select "Show non-English" or "Zoom non-English". As shown, non-English fields have a bisque-beige color.
"NE Lang" button, for viewing all non-English fields on the sub-tab.
Label generation options
When you click on the Label button and select an FDA label from the menu, the program presents a dialog of options:
"Select label generation options" dialog.
Omit: Product name
Your company logo may already include the product name, in which case having the product name appear directly beneath the logo may be redundant.
Omit: Product logo
· The product logo is the first item on the "Label content 1" sub-tab.
· If you want to display the product name as text, but don't want to include a product logo above the text, check this box.
Place company logo below Drug Facts box (normally above)
· The company logo is normally just above the "Size/amount" field on the entry form, which itself is above the Drug Facts box.
· Checking this box places the company logo immediately below the Drug Facts box, next to the company name and address.
· The company logo appears on Tab "1 Identification", in the "Supplier" sub-tab, near the bottom of the form. If that entry is empty, then the program will use the logo in Preferences, if one is available there.
Alphabetize inactive ingredients
· The program will default to using the order of items in the Component table on Tab "3 Composition", unless you check this box.
· Inactive ingredients for an OTC drug product (with no cosmetic content) should be alphabetized. For this type of product, you should check this box.
· Inactive ingredients for a combined drug-cosmetic product should be listed non-alphabetically in the product, so for this type of product do not check this box.
Scaling: Product logo and Company logo
Use this setting to scale the logo on the generated label between 20 and 200 percent of its normal size. Values of zero or 100 result in no scaling.
Scaling: Drug Facts box width
This setting determines the width of the Drug Facts box relative to the width of the column(s) on the page. If you have selected only one column (in the "Number of Columns" option), then the Drug Facts box will be wider than it would had you selected two or three columns.
Number of columns (range 1-3)
· Enter a number between one and three for the number of columns you would like to appear on the page.
· Use of three columns results in a landscape rather than a portrait page setup.
· If the Drug Facts box/portion of the label when printed runs to more than one panel of the product package, then each additional panel will require a "Drug Facts (continued)" label at the top, with a separator line. You can create these manually at the desired locations, in the word processing area.
Use an alternate font
The default font for most of the FDA label text is Arial Narrow. If the program does not find Arial Narrow in your system, then the program will look for Calibri, and finally for Arial. The default font for the product name is either Freestyle Script or Segoe Print (if found in your system).
However, you can select a different font for all label text, from the drop-down menu. In this case, ensure that the “Use an alternate font” box is checked.
[rev. 8.19.2021]
[1] You can also find this search under "FDA online label repository", in the Research menu.
[2] An OTC drug monograph is the product of an FDA over-the-counter (OTC) drug review, which establishes standards for labeling, indications, dosage instructions, and warnings.
[3] This shortcut is equivalent to clicking on the Help button on the entry form, and selecting “Background for this section”.
[4] The program places the "tamper evident:…" statement above the Drug Facts box (just above the NDC number, if entered).