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Guidance for Industry
Labeling OTC Human Drug
Products — Questions and
Answers
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
December 2008
OTC
Guidance for Industry
Labeling OTC Human Drug
Products — Questions and
Answers
Additional copies are available from:
Office of Communications
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 51, rm. 2201
Silver Spring, MD 20993
E-mail: [email protected]
Fax: 301-847-8714
(Tel) 301-796-3400
http://www.fda.gov/cder/guidance/index.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
December 2008
OTC
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND ............................................................................................................... 1
III. CONTENT LABELING REQUIREMENTS................................................................. 2
IV. FORMAT LABELING REQUIREMENTS................................................................... 8
V. EXEMPTIONS AND DEFERRALS............................................................................. 13
APPENDIX A: SUMMARY OF LABELING REQUIREMENTS....................................... 15
Contains Nonbinding Recommendations
Guidance for Industry 1
Labeling OTC Human Drug Products —
Questions and Answers
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does
not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can
use an alternative approach if the approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number
listed on the title page of this guidance.
I. INTRODUCTION
This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter
(OTC) drug products who have questions about the standardized labeling content and format
requirements set forth in 21 CFR 201.66. The examples in this guidance illustrate various format
and content features of the labeling requirements and show how OTC drug monograph labeling
information can be converted to the OTC Drug Facts labeling format. This guidance is one in a
series of Food and Drug Administration (FDA) guidances intended to facilitate compliance with the
labeling requirements in § 201.66.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. BACKGROUND
In the Federal Register of March 17, 1999 (64 FR 13254), the FDA published a final regulation
(§ 201.66) establishing standardized content and format for the labeling of OTC drug products (Drug
Facts labeling). The Drug Facts labeling for OTC drug products is intended to make it easier for
consumers to read and understand OTC drug product labeling and use OTC drug products safely
and effectively. The Drug Facts labeling regulation in § 201.66 covers all OTC drug and drug-
1
This guidance has been prepared by the Office of Nonprescription Products in the Center for Drug Evaluation and
Research (CDER) at the Food and Drug Administration.
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Contains Nonbinding Recommendations
cosmetic products, whether marketed under a new drug application (NDA), abbreviated new drug
application (ANDA), or OTC drug monograph (or drug product not yet the subject of a final OTC
drug monograph). 2
The regulation is divided into two main parts: 1) content requirements in paragraph (c) (i.e.,
headings, subheadings, and the order in which certain information must be listed); and 2) format
requirements in paragraph (d) (i.e., graphic specifications). This guidance primarily discusses
questions received from manufacturers, packers, and distributors relating to these requirements,
which are set forth in §§ 201.66(c) and (d), respectively.
III. CONTENT LABELING REQUIREMENTS
The following questions and answers address the OTC Drug Facts labeling requirements in
§ 201.66. Tables A and B in Appendix A list the specific section-by-section requirements in
§§ 201.66(c) and (d) as well as the expectations for implementing the requirements in the
regulation. These tables should be referred to for details on specific requirements.
Question 1: What labeling information do the regulations require for all OTC drug products?
Answer 1: Section 201.66 requires that all OTC drug product labeling contain the following
information about the drug product. This information must be organized according
to the following headings and must be presented in the following order:
1. Title (Drug Facts or Drug Facts (continued))
2. Active ingredient(s)
3. Purpose(s)
4. Use(s)
5. Warning(s)
6. Directions
7. Other information
8. Inactive ingredients
9. Questions? or Questions or comments? (optional)
This information must appear on the outside container or wrapper of the retail
package, or the immediate container label if there is no outside container or wrapper.
(If the Drug Facts information appears on the outside container or wrapper of the
retail package, its use on the immediate container is optional. See Appendix A.)
2
The text of § 201.66 can be found at the Division of Dockets Management Web site located at
http://www.fda.gov/cder/otc/label/label-fr-reg.htm.
2
Contains Nonbinding Recommendations
Question 2: Why must the title Drug Facts (continued) appear on each subsequent panel in
which the Drug Facts labeling appears?
Answer 2: The title Drug Facts must appear on the first panel and the title Drug Facts
(continued) must appear on each subsequent panel to ensure that the person reading
the labeling can follow through to the end of the labeling (§ 201.66(c)(1)).
Question 3: What indications can be included in the Use(s) section if the product is a drug-
cosmetic product?
Answer 3: For drug-cosmetic products, only the drug-related indications can be included in the
Use(s) section.
Question 4: Is there a required order for listing subject-specific warnings?
Answer 4: Section 201.66(c) requires that warnings in paragraph (c)(5) appear in the order
listed.
Question 5: What information must appear under the Warnings subheading Do not use? Can
I convert the text of existing warnings in final OTC drug monographs or approved
applications to the bulleted statement format under this subheading?
Answer 5: The Do not use subheading (§ 201.66(c)(5)(iii)) is reserved for: 1) drug products
that should not be used unless a previous diagnosis has been made by a doctor; or 2)
drug products that should not be used under any circumstances by certain consumers,
regardless of whether a doctor or health care professional is consulted.
Manufacturers can convert existing formats to the Drug Facts labeling format. For
example, the current warning “Do not use this product unless a diagnosis of asthma
has been made by a doctor” can be placed under the subheading Do not use and
shortened to read “unless a diagnosis of asthma has been made by a doctor” (i.e.,
“Do not use unless a diagnosis of asthma has been made by a doctor”).
Question 6: How can I convert a lengthy warning under the subheading Ask a doctor before
use if you have into the bulleted text format?
Answer 6: Here is an example: The warning for oral and topical antitussives states: “Do not
take this product for persistent or chronic cough such as occurs with smoking,
asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
unless directed by a doctor.” Under this subheading, this warning can be converted
into bulleted statements as follows:
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Contains Nonbinding Recommendations
Ask a doctor before use if you have
● cough that occurs with too much phlegm (mucus)
● chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or
emphysema
Question 7: How can I convert the OTC antihistamine drug product warning “Do not take this
product if you are taking sedatives or tranquilizers without first consulting your
doctor” into bulleted text?
Answer 7: This warning could appear as follows:
Ask a doctor or pharmacist before use if you are taking sedatives or
tranquilizers
or
Ask a doctor or pharmacist before use if you are taking ● sedatives
● tranquilizers
Question 8: What information must appear under the subheading When using this product?
How can I convert text of existing required warnings to bulleted text format under
this subheading?
Answer 8: This subheading must be used for side effects that consumers may experience
(§ 201.66(c)(5)(vi)). It identifies substances (e.g., alcohol) or activities (e.g.,
operating machinery, driving a car) that should be avoided while using the drug product.
This subheading also must include warnings for drugs in dispensers pressurized by
gaseous propellants. Such information would appear in bulleted text format as
follows:
● may cause drowsiness [or may appear as: ● drowsiness may occur]
● alcohol, sedatives, and tranquilizers may increase the drowsiness effect [or
may appear as: ● alcohol, sedatives, and tranquilizers may increase
drowsiness]
● do not puncture or incinerate; contents under pressure.
Question 9: What information must appear under the subheading Stop use and ask a doctor
if?
Answer 9: You must include under the Stop use… subheading any signs of toxicity or other
reactions that would require a consumer to immediately stop using the drug product
(§ 201.66(c)(5)(vii)). For example, the bulleted statement “you get nervous, dizzy,
or sleepless” would appear in this section.
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Contains Nonbinding Recommendations
Question 10: Where must I put warnings required in an applicable OTC drug monograph, in
other OTC drug regulations, or in an approved drug application that do not
otherwise fit under the Warnings heading or subheadings?
Answer 10: Such warnings must be placed in the Drug Facts Warnings section. For example,
chlorofluorocarbons (CFC) warnings, required in certain approved drug applications,
must be put in the Warnings section. The warning would appear as follows:
“Contains CFC-[insert number] and CFC-[insert number], substances that harm
public health and the environment by destroying ozone in the upper atmosphere”
(§ 201.320).
Question 11: Where must pregnancy information and related warnings be placed?
Answer 11: When applicable, these types of warnings also must be placed in the second-to-last
subsection of the Warnings section. Warnings may include one or more of the
following:
• The pregnancy/breast-feeding warning
• The third trimester warning for drug products containing aspirin or carbaspirin
calcium
• The third trimester warning in approved drug applications for drug products
containing ketoprofen, naproxen sodium, or ibuprofen (if not intended
exclusively for use in children)
Question 12: Should all OTC drug product labeling include the Keep out of reach of children
and the accidental overdose/ingestion warnings?
Answer 12: In most cases, these warnings are required for OTC drug products and therefore
must be included in the Drug Facts box. In a few special instances, the Keep out
of reach of children warning may be omitted. (See lipstick with a sunscreen in
§ 352.52(f)(1)(vi).) The accidental overdose/ingestion warning also may be omitted
in some instances, as specified in an applicable OTC drug monograph or approved
drug application.
Question 13: Do I have to present information under Directions in a table format?
Answer 13: Depending on the drug product, the directions can appear completely in a table, as a
number of bulleted statements, or as a combination of a table and bulleted
statements. For example, a table format must be used when dosage directions are
provided for three or more age groups or populations (§ 201.66(d)(9)). Dosage
directions provided for one or two age groups or populations can be presented using
bulleted statements. However, a table format can be used for two age groups or
populations if it helps make the presentation of the information clearer and easier to
read.
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Contains Nonbinding Recommendations
Under this heading, information other than age groups should appear as bulleted
statements. For example:
● shake well
● drink a full glass (8 oz) of liquid with each dose
● do not use more than directed
adults and children 12 years and 2 tablets every 6 hours
older
children 6 – 12 years 1 tablet every 6 hours
children under 6 years ask a doctor
Question 14: What information must be included under the heading Other information?
Answer 14: This section must include information that is not included under the other headings
or subheadings, but is required or is made optional under an OTC drug monograph,
other OTC drug regulation, approved drug application, statute, or OTC drug
guidance.
If applicable, the first bulleted statement under this heading must include calcium,
magnesium, potassium, and sodium to read as follows: “each (insert appropriate
dosage unit) contains: [in bold type] (insert name(s) of ingredient(s) and quantity of
each ingredient)” (§§ 201.70, 201.71, 201.72, and 201.64, respectively). See also
§ 201.66(c)(7)(i).
If applicable, phenylalanine/aspartame content shall appear as the next item as
follows: “Phenylketonurics: Contains Phenylalanine (insert quantity) mg per (insert
appropriate dosage unit).” This statement must be listed as the first bulleted
statement under this heading or the second bulleted statement if Ca, Mg, K, or Na is
(are) present. For example:
Other information
● each tablet contains: calcium 10 mg, magnesium 10 mg, and sodium 15 mg
● Phenylketonurics: Contains Phenylalanine 10 mg per tablet
● [insert storage conditions] if applicable
● [insert tamper-evident statement]
Question 15: Where must the tamper-evident statement appear in my OTC drug product
labeling?
Answer 15: The tamper-evident statement must be prominently placed on the drug product
package to alert consumers about the drug product’s tamper-evident features (21
CFR 211.132). The tamper-evident statement describes the tamper-evident feature
of the drug product package and advises consumers that, if the feature is breached or
missing when the drug product is purchased, tampering may have occurred.
Tamper-evident packaging with an appropriate labeling statement will be more likely
to protect consumers because the consumer will be in a better position to detect
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Contains Nonbinding Recommendations
tampering when he or she has knowledge that a tamper-evident feature has been
incorporated into the drug product design. We allow flexibility in the placement of
this statement on the package and do not require that it be included within the Drug
Facts section. However, if included in this section, the statement must appear under
the heading “Other information” (see § 201.66(c)(7)).
We also noted in the final rule preamble for the Drug Facts regulation that many
drug products are now marketed with peel back or fold out labels affixed to the drug
product package and that these labels could be used to accommodate all of the FDA
required information in the Drug Facts section (64 FR 13254 at 13268; March 17,
1999). These types of labels were not in use at the time the tamper-evident
requirements became effective. Recently, interested parties have inquired whether
the tamper-evident statement may be included in a Drug Facts section that appears in
such peel back or fold out labels. We believe that the goals of the tamper-evident
statement would likely not be achieved if the statement only appears in a peel back
or fold out label and is not clearly visible without peeling back or folding out the
label.
It is important that the consumer view the tamper-evident statement before purchase
and use of the drug product so that he or she will be better aware of the tamper-
evident features and any signs of tampering. Once the consumer opens the tamper-
evident package, the tamper-evident features have been breached. If the consumer
has failed to examine these features before opening, then the consumer will likely
not know if there were any signs of tampering. A tamper-evident statement inside a
peel back or fold out label that is not visible on the outside of the package is unlikely
to be viewed before breach of the tamper-evident feature. The consumer may not be
aware to peel back or unfold this label to view the tamper-evident statement before
opening the package. Thus, we recommend that the statement not appear within the
Drug Facts box in a peel back or fold out label if the statement would not be clearly
visible without peeling back or folding out the label. We recommend instead in
these circumstances that the tamper-evident statement be outside the Drug Facts box
in another part of the label where the statement is clearly visible without further
manipulation of that label.
Question 16: Do I have to list the inactive ingredients in my OTC drug product labeling in
alphabetical order?
Answer 16: It depends.
For OTC drug products that are not also cosmetic products, the established name of
each inactive ingredient must be listed in alphabetical order (§ 201.66(c)(8)). For
example, the Inactive ingredients section would appear as follows:
Inactive ingredients colloidal silicon dioxide, FD&C blue #1 lake,
hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene
glycol, povidone, propylene glycol, titanium dioxide
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Contains Nonbinding Recommendations
For an OTC drug product that is a drug-cosmetic product, the inactive ingredients
must be listed in descending order of predominance in the drug product formulation
(§§ 201.66(c)(8) and 701.3(a)). For example, the Inactive ingredients section
would appear as follows:
Inactive ingredients water, sorbitan isostearate, sorbitol, triethanolamine, stearic
acid, barium sulfate, benzyl alcohol, dimethicone, methylparaben, aloe extract,
carbomer, disodium EDTA
Question 17: Do I have to include a Questions? section in the Drug Facts box or similar
enclosure?
Answer 17: No. Although this heading and subsequent information are not required, we
encourage all manufacturers, packers, and distributors to include in this section a
telephone number of a source to answer questions about the drug product or to
receive reports of adverse events associated with the use of the drug product.
Although not permitted to appear in or otherwise interrupt the required Drug Facts
labeling information, brand names or drug product attributes can appear in the
telephone number and/or in the Web site address, if used. However, if the telephone
number appears as letters of the brand name or drug product attribute, we
recommend that the manufacturer also include the numerical representation of the
telephone number in this section.
IV. FORMAT LABELING REQUIREMENTS3
Question 18: How must the content labeling requirements be presented within the Drug Facts
box or similar enclosure?
Answer 18: All features of the Drug Facts box or similar enclosure and the required content
information must be presented according to graphic specifications, which are listed in
Table B in Appendix A (see also §§ 201.66(c) and (d)).
Question 19: Can I use bold type for any information I consider needs greater prominence?
Answer 19: We recommend that you avoid using bold type in the immediate area where existing
regulations require specific text be in bold type.
Question 20: How should fractions be expressed within the Drug Facts box?
Answer 20: Fractions (e.g., 1/2) can be expressed in mathematical notation or text format (i.e.,
one-half). The text must be in the same single, clear, easy-to-read type style and
3
See Table B in Appendix A for specific format labeling requirements in § 201.66(d).
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Contains Nonbinding Recommendations
type size used for the other text included in the Drug Facts box. If expressed in
mathematical notation, each component of the numerical notation must be no smaller
than 6-point type.
Question 21: How should I arrange additional text related to a single bulleted statement?
Answer 21: We recommend that additional text be formatted as indented sub-bulleted statements.
For example:
Uses
● temporarily relieves pain and itching due to:
● insect bites ● minor skin irritations
● dries the oozing and weeping of:
● poison ivy ● poison oak ● poison sumac
Question 22: Can I begin a bulleted statement on the same line as a heading or subheading?
Answer 22: Yes. However, no bulleted statement or text can appear on the same line as the
Warnings heading.
Question 23: Should bulleted statements be left justified when using the standard labeling
format?
Answer 23: Yes. The first bulleted statement on each horizontal line of text must be left
justified, except if the bulleted statement appears on the same line of an appropriate
heading or subheading (§ 201.66(d)(4)). Any bulleted statements that do not fit
entirely on a multi-bulleted line should begin left justified on the following line.
(Note: no bulleted statement or text can appear on the same line as the Warnings
heading.) For example:
Ask a doctor before use if you have
● heart disease ● glaucoma ● high blood pressure
● thyroid disease ● diabetes
● trouble urinating due to an enlarged prostate gland
● a breathing problem such as emphysema or chronic bronchitis
Question 24: Should bulleted statements be aligned with the bulleted statements on the previous
line when using the modified labeling format?
Answer 24: No. Using this format, bulleted statements do not need to be aligned and can
continue to the next line of text (§ 201.66(d)(10)(iv)). For example:
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Ask a doctor before use if you have ● heart disease ● glaucoma
● high blood pressure ● thyroid disease ● diabetes ● trouble urinating due
to an enlarged prostate gland ● a breathing problem such as emphysema or
chronic bronchitis
Question 25: Where can I find guidance on the use of a column format as part of the new OTC
drug labeling requirements?
Answer 25: The guidance for industry Labeling OTC Human Drug Products Using a Column
Format is available on the CDER Web site.4 A written request for a copy can be
sent to the Division of Drug Information, Center for Drug Evaluation and Research,
FDA, 10903 New Hampshire Avenue, Bldg. 51, rm. 2201, Silver Spring, MD
20993-0002.
Question 26: How can I obtain copies of other FDA labeling guidances relating to the new OTC
drug labeling requirements?
Answer 26: Copies of related guidances are available on the Internet,5 or send a written request
for single copies to the Division of Drug Information (see address above).
Question 27: How must I list ingredients under the heading Active ingredient(s)?
Answer 27: The ingredients must be listed in alphabetical order (§ 201.66(d)(6)).
Question 28: How should I list under the heading Purpose(s) ingredients with the same
pharmacological action?
Answer 28: When more than one active ingredient has the same purpose, the information can be
presented in a manner that readily associates each active ingredient with its purpose
(by using brackets, dot leaders, or other graphical features). For example:
Active ingredients Purpose
Homosalate 6% }
Oxybenzone 3% } ....................................Sunscreen
Padimate O 2% }
Question 29: How should I list inactive ingredients that may or may not be contained in my
drug product?
Answer 29: These ingredients should be listed in alphabetical order along with those ingredients
that are contained in your drug product. We recommend that you place an asterisk
next to those ingredients that, depending on the source, may or may not be contained
4
See http://www.fda.gov/cder/guidance/index.htm.
5
Ibid.
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in the drug product (e.g., acacia*, dextrose*, sucrose, xanthum gum*). The asterisk
should be referenced at the bottom or end of the inactive ingredient section in the
Drug Facts box, with the notation “* contains one or more of these ingredients” (if
more than one ingredient may or may not be in the drug product), or “* may contain
this ingredient” (if only one ingredient may or may not be in the drug product),
whichever is appropriate.
We recommend that for drug product labeling using the standard labeling format as
described in §§ 201.66(d)(1) through (d)(9), the statement (“* contains one or more
of these ingredients,” or “* may contain this ingredient,” whichever is appropriate)
should be left justified at the end of the inactive ingredient section. The type size of
these statements must be at least 6-point type. For drug product labeling that uses
the modified format as described in § 201.66(d)(10), the asterisk statement could
appear on the same line as the last listed inactive ingredient if separated from the last
listed ingredient by at least two square ems.6
Listing too many alternative ingredients could be misleading and may cause
consumer confusion. To avoid such confusion, manufacturers, packers, and
distributors may wish to consider using a second set of labels for drug products with
a lengthy list of different inactive ingredients.
Additionally, to provide consumers with the opportunity to learn if an ingredient is
in the lot number of the drug product, we recommend that the optional information
in § 201.66(c)(9) (Questions? or Questions or comments? followed by the
telephone number of a source to answer questions about the drug product) be
included in the labeling.
Manufacturers, packers, and distributors are also reminded to follow all applicable
current good manufacturing practice regulations in 21 CFR part 211 for finished
pharmaceuticals so that manufacturers maintain appropriate records showing which
lot numbers of the drug product contain which inactive ingredients.
Question 30: Can I use a pictogram or graphical image such as the Universal Product Code
(UPC) symbol within the Drug Facts box?
Answer 30: No. The only pictogram that may be included within the Drug Facts information is a
telephone or telephone receiver before the Questions? heading. Pictograms and
graphical images such as the UPC symbol cannot appear in, or in any way interrupt, the
information required in the Drug Facts labeling (§ 201.66(d)(7)). They can appear
outside the Drug Facts box. The following examples illustrate how the UPC code can
be placed in relation to the Drug Facts box.
6
Two square ems are two squares of the size of the letter M. (See § 201.66(d)(4).)
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Illustration 1. Illustration 2. (showing second panel)
Drug DF
Facts
Labeling DF
(DF)
UPC
UPC
Question 31: When can I use the modified labeling format?
Answer 31: When the required Drug Facts content information printed in the standardized format
plus any other FDA required information for drug or drug-cosmetic products, other
than information required to appear on the principal display panel, requires more
than 60 percent of the total surface area available to bear labeling (§ 201.66(d)(10)).
Question 32: What is the difference between the standard and modified labeling formats?
Answer 32: Table 1 illustrates the differences between the two labeling formats.
Table 1. Standard Versus Modified Labeling Format
Labeling Standard Format Modified Format
Element
Drug Facts box Set off by barline Barline may be omitted if color contrast
used to set off from the rest of the labeling
Drug Facts Larger than largest type Larger than largest type size used in the
size used in Drug Facts box Drug Facts box or similar enclosure
or similar enclosure
Drug Facts No smaller than 8-point No smaller than 7-point type
(continued) type
Headings >8-point type, or 2-point >7-point type, or 1-point type > point size
type > point size of text of text
Subheadings No smaller than 6-point No smaller than 6-point type
type
Bulleted text No smaller than 6-point No smaller than 6-point type
type
Leading Minimum 0.5-point type Smaller than 0.5-point type can be used,
provided the ascenders and descenders do
not touch
Bullets Minimum 5-point type Minimum 5-point type
Vertical alignment No alignment required
Question 33: What other labeling requirements may be applicable in addition to the
standardized content and format requirements in § 201.66?
Answer 33: Additional labeling requirements in 21 CFR parts 201 and 211 that may be
applicable are summarized in Table 2 as follows:
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Table 2. Additional Labeling Requirements
Paragraph Description of Paragraph
§ 201.1 Name and place of business of manufacturer, packer, or
distributor
§ 201.17 Location of expiration date
§ 201.18 Control numbers
§ 201.60 Principal display panel
§ 201.61 Statement of identity
• Established name of drug product
• Statement of general pharmacological category(ies) or the
principal intended actions
• Bold type
• Size related to the most prominent printed matter
§ 201.62 Declaration of net quantity of contents
§ 201.20 Declaration of the presence of FD&C Yellow No. 5 and/or
FD&C Yellow No. 6
§ 211.132(c) Tamper-evident labeling
Question 34: When must my product comply with the new OTC drug labeling requirements?
Answer 34: All OTC drug products must be in compliance with § 201.66 at this time, except for
the following:
• The FDA has granted a stay of compliance for implementation of the Drug Facts
regulation until further notice (67 FR 16304; April 5, 2002) for OTC drug
products that contain no more than two doses of an OTC drug product and,
because of their limited surface area available to bear labeling, qualify for the
labeling modifications set forth in § 201.66(d)(10).
• The FDA has granted a stay of compliance for implementation of the Drug Facts
regulation until further notice (69 FR 53801; September 3, 2004) for OTC
sunscreen drug products. This stay also applies to OTC sunscreen drug-cosmetic
products.
V. EXEMPTIONS AND DEFERRALS
Question 35: Are there any exemptions or deferrals to the Drug Facts labeling requirements?
Answer 35: Section 201.66(e) provides that the FDA on its own initiative or in response to
written request from any manufacturer, packer, or distributor may exempt or defer,
based on the particular circumstances presented, one or more specific requirements
set forth in §§ 201.66(a) through (d), on the basis that the requirement is
inapplicable, impracticable, or contrary to public health or safety. The FDA points
out that exemption and deferral requests shall: 1) document why a particular
requirement is inapplicable, impracticable, or is contrary to public health or safety;
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and 2) include a representation of the proposed labeling, including any outserts,
panel extensions, or other graphical or packaging techniques intended to be used
with the drug product. The FDA reviews each exemption and deferral request
submitted and, based on the data submitted,


Use: 0.3282