Guidance for Industry
Labeling OTC Skin Protectant Drug Products

(PDF version of this document)

DRAFT GUIDANCE

            This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact Matthew Holman at 301-827-2222.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

August 2003
OTC

Guidance for Industry 1.
Labeling OTC Skin Protectant Drug Products

I.          INTRODUCTION

This draft guidance is intended to describe the final monograph for over-the-counter (OTC) skin protectant drug products, found in 21 CFR part 347.  In this monograph, skin protectant drug products are defined as drug products that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces (§ 347.3).  Skin protectant drug products include lip protectant drug products, typically referred to as lip balms.  The guidance focuses on the labeling of skin protectant drug products with single or multiple active ingredients as well as with skin protectant active ingredients that are combined with active ingredients from other OTC drug monographs.

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

On August 4, 1978 (43 FR 34628), FDA published in the Federal Register an advance notice of proposed rulemaking to establish a monograph for OTC skin protectant drug products.  The Agency then published a tentative final monograph, or proposed regulation, for OTC skin protectant drug products in the Federal Register on February 15, 1983 (48 FR 6820).  On October 3, 1989 (54 FR 40808), the Agency published a notice to amend the tentative final monograph to include OTC skin protectant drug products for poison ivy, oak, and sumac and for the treatment and/or neutralization of insect bites.  Finally, on Friday, June 4, 2003 (68 FR 33362), the Agency issued a final monograph for skin protectant drug products.  The final monograph also amends the final monograph for OTC skin protectant drug products used as astringents in 21 CFR 347, which published on October 21, 1993 (58 FR 54458).  Moreover, the final monograph incorporates standardized labeling content and format requirements established by the Agency in the Federal Register of March 17, 1999 (64 FR 13254, 21 CFR 201.66).

This guidance is intended to help interested parties understand the final monograph for OTC skin protectant drug products and meet the requirements of the final monograph. 

III.       SKIN PROTECTANT ACTIVE INGREDIENTS

A.        Which skin protectant active ingredients have special requirements?

There are 19 OTC skin protectant active ingredients generally recognized as safe and effective (§ 347.10).  Three active ingredients have special requirements:  cod liver oil, colloidal oatmeal, and mineral oil.  A skin protectant drug product containing cod liver oil as an active ingredient must also include one or more of the other 18 active ingredients.  In addition, a skin protectant drug product containing cod liver oil must be manufactured in such a way that, when the product is used consistent with labeling, consumer exposure to vitamin A and cholecalciferol does not exceed 10,000 USP units and 400 USP units, respectively, in a 24-hour period (§ 347.10(e)).  A skin protectant drug product can contain colloidal oatmeal or mineral oil as a single active ingredient at a minimum of 0.007 percent or 50 to 100 percent, respectively.  However, a skin protectant drug product containing both colloidal oatmeal and mineral oil needs a minimum of 0.003 percent and 30 to 35 percent, respectively, of each active ingredient (§ 347.10).

B.        Which skin protectant active ingredients can be combined?

Although there are some limitations, all skin protectant active ingredients, except sodium bicarbonate and topical starch, can be combined with one or more other skin protectant active ingredients listed in § 347.10.  In fact, a skin protectant drug product containing cod liver oil must also contain another active ingredient (§ 347.10).  In all instances, except the combination of colloidal oatmeal and mineral oil, the allowed concentrations of each active ingredient should remain the same whether as a single active ingredient or in combination with other active ingredients (§ 347.20).  The previous section of this guidance regarding skin protectant active ingredients describes the amount of colloidal oatmeal and mineral oil required when combined with each other. 

The following list outlines the three groups of skin protectant active ingredients that can be combined with each other according to § 347.20(a):

• Allantoin, cocoa butter, cod liver oil, dimethicone, glycerin, hard fat, lanolin, mineral oil, petrolatum, white petrolatum
• Aluminum hydroxide gel, calamine, kaolin, zinc acetate, zinc carbonate, zinc oxide
• Colloidal oatmeal, mineral oil

The active ingredients in each group can be combined only with the other active ingredients in the same group.  Active ingredients in different groups cannot be used in the same drug product.  For example, cocoa butter can be combined with glycerin, but not with aluminum hydroxide gel. 

C.        Can skin protectant active ingredients be combined with active ingredients from other OTC drug monographs?

Yes, a skin protectant drug product can contain external analgesic, first aid antiseptic, or sunscreen active ingredients in combination with skin protectant active ingredients.  Table 1 specifies the active ingredients from the respective OTC drug monographs that can be combined according to §§ 347.20(b), (c), and (d).

Table 1.  Permitted Combinations of Skin Protectant Active Ingredients

The permitted combinations listed in Table 1 may be expanded or revised as the Agency completes the rulemakings for OTC external analgesic, first aid antiseptic, and sunscreen drug products.  As these final rules are completed and their list of permitted combinations is developed, the permitted combinations in the skin protectant final monograph will be revised so that it is consistent with these final rules.  For example, the agency did not address combinations of skin protectant and external analgesic active ingredients for the uses in §§ 347.60(b)(2) and (b)(3) because all of the labeling for these combination products has not been fully developed.  Therefore, until the Agency issues the final monograph for OTC external analgesic drug products, products allowed under the external analgesic tentative final monograph for claims covered by § 347.60(b)(2) and (b)(3) may continue to be marketed.  This includes allowable external analgesic active ingredients combined with skin protectant lip protectants containing dimethicone or skin protectant poison ivy protectants containing calamine.

D.        Are there any ingredients that cannot be used as skin protectant active ingredients?

Yes, the Agency received insufficient data to establish that certain ingredients are generally recognized as safe and effective skin protectants.  Therefore, these ingredients are not permitted as skin protectant active ingredients.  They are listed in 21 CFR 310.545(a)(18). 

IV.       LABELING SKIN PROTECTANT DRUG PRODUCT

A.        What are the general labeling content and format requirements?

After the tentative final monograph for OTC skin protectant drug products was published on February 15, 1983, the Agency issued a final rule standardizing the content and format for labeling OTC drug products.  This final rule was published in the Federal Register on March 17, 1999 (64 FR 13254).  Among other changes, the final rule amended 21 CFR 201.66 to require that OTC drug products include a Drug Facts box containing each active ingredient and corresponding purpose (statement of identity), indications, warnings, and directions among other information.  Therefore, labeling for an OTC skin protectant drug product must include a Drug Facts box to comply with § 201.66.  The attachment to this guidance provides a sample Drug Facts box that complies with the regulations described in this guidance.
 

B.        What is the appropriate statement of identity(Purpose) for my drug product?

The statement of identity must appear on the principal display panel and in Drug Facts under the Purpose heading according to §§ 201.61 and 201.66(c)(3), respectively.  The permitted statement of identity for an OTC skin protectant drug product is dependent on the active ingredients.  Any skin protectant drug product can include “skin protectant” as the statement of identity.  In addition, those OTC skin protectant drug products containing the following active ingredients may include “poison ivy, oak, sumac drying” as the statement of identity: aluminum hydroxide gel, calamine, kaolin, zinc acetate, zinc carbonate, and zinc oxide.  The statement of identity for any OTC skin protectant drug product can also include the dosage form.  For example, the statement of identity for a lotion containing cocoa butter could be “skin protectant” or “skin protectant lotion.”

C.        What are the appropriate indications (Uses) for my drug product?

The indications of each active ingredient must be stated under the Uses heading within Drug Facts as required by § 201.66(c)(4).  Table 2 summarizes skin protectant indications that can be stated under the Uses heading, including optional indications for certain active ingredients.  These indications are included in the labeling whenever a skin protectant active ingredient is present in a drug product, whether as a single active ingredient or in combination with other skin protectant, external analgesic, first aid antiseptic, or sunscreen active ingredients, as detailed in Table 1.

Table 2.  Skin Protectant Indications

1Optional wording is indicated by italic font.  The italic font should not be included in labeling.
2 Only one of these bulleted statements is required by 21 CFR 347.50(b)(2).  The first bulleted statement is used if the skin protectant drug product is not formulated as a lip protectant.  The second bulleted statement is used if the skin protectant drug product is formulated as a lip protectant.   
3 This bulleted statement is optional.  If this statement is not included in labeling, do not place a bullet before the first or second statement.
4 May use any one of the listed statements.
5 Select one or more terms within the parentheses.  Parentheses should not be included in labeling.  If only one term is used, do not use a bullet.

D.        What are the appropriate Warnings for my drug products?

There are a few warnings that are required in the labeling of OTC skin protectant drug products (§ 347.50(c)). The skin protectant active ingredient and, in some cases, the labeled indication (as shown in Table 3) determines which warning is required.  All applicable warnings must be included in skin protectant drug product labeling, even if the drug product contains any external analgesic, first aid antiseptic, or sunscreen active ingredients (§ 201.66(c)(5)(viii)).

Table 3.  Skin Protectant Warnings

1 Use warning if ingredient is combined with an ingredient other than cocoa butter, petrolatum, or white petrolatum.

E.        What are the appropriate Directions for using my drug product?

The directions for an OTC skin protectant drug product are determined by the active ingredient and, for colloidal oatmeal and sodium bicarbonate, dosage form as described in Table 4.  If specific directions are not listed in Table 4 for a particular active ingredient, the directions are “apply as needed,” in accordance with § 347.50(d).

V.        SPECIAL LABELING REQUIREMENTS OR EXCEPTIONS FOR SKIN PROTECTANT DRUG PRODUCTS

A.        Are lip protectants with small packaging allowed reduced labeling?

Yes, OTC lip protectant drug products, including those with sunscreen active ingredients, are allowed reduced labeling if marketed in small packages with space limitations that prevent complete labeling as defined in 21 CFR 201.66(d)(10).  Much of the abbreviated labeling is captured in Tables 2-4, but the following list summarizes all labeling requirements that can be omitted:

• Drug Facts title
• Purpose heading and related information
• All information under Warnings except the revised statement: "Stop use and ask a doctor if condition lasts more than 7 days"
• Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.  (21 CFR 330.1(g))
• Directions heading and related information
• Other information heading
• Questions heading and related information
• Barlines and hairlines if information is presented in a color that contrasts with the rest of the labeling

In addition, the Uses heading may be reduced to the following: "Use helps protect chapped lips" or "Use helps protect and relieve chapped lips."

Table 4.  Skin Protectant Directions

1 Manufacture must also include directions to obtain solution with appropriate concentration of colloidal oatmeal in accordance with 21 CFR 347.50(d)(2)(A) and (B).
2 Parentheses mark insertion point for colloidal oatmeal amount and should not be included in labeling.

B.        Are skin protectant drug products containing cocoa butter, petrolatum, and/or white petrolatum allowed reduced labeling?

Yes, OTC skin protectant drug products containing cocoa butter, petrolatum, or white petrolatum as a single active ingredient or in combination with each other are allowed reduced labeling according to 21 CFR 347.50(f).  Much of the special labeling is captured in Tables 2 to 4, but the following list summarizes all labeling requirements that can be omitted:

• Purpose heading and related information
• For external use only
• “Apply as needed” under Directions
• Other information heading
• Questions heading and related information

Uses may be reduced to one of the following statements:

• Use helps protect minor cuts and burns
• Use helps protect chapped skin
• Use helps protect minor cuts and burns and chapped skin

As stated in § 347.50(f)(1)(iii) and (iv), Warnings must contain the following shortened statements or the corresponding full-length statements listed in § 347.50(c):

• See a doctor if condition lasts more than 7 days
• Do not get into eyes
• Do not use on · deep or puncture wound  · animal bites  · serious burns

C.        What are the labeling requirements for skin protectant drug products containing active ingredients from other OTC drug monographs?

Table 1 lists permitted combinations of skin protectant active ingredients.  If skin protectant active ingredients are combined with active ingredients from the specified OTC drug monographs, the requirements of each applicable OTC drug monograph must be met.  However, labeling statements can be combined to eliminate duplicative words and phrases to produce clear, understandable statements that include all required information.  In some cases, there may be conflicting dosing directions such as different time intervals between doses or different minimum age limits.  In such situations, the safest dosing direction should be used.  Specifically, the dosing time interval that allows the most time between doses or the highest minimum age of different active ingredients should be used.  For example, if one active ingredient can be used by children 12 years and over while another active ingredient can be used by children 6 years and over, the product should be labeled for use by children 12 years and over. Finally, cosmetic ingredients and skin protectant active ingredients may be combined in a single product as long as cosmetic ingredients and drug active ingredients are listed separately.  All of the cosmetic ingredients appear under Inactive ingredients heading in the manner set forth in 21 CFR 701.3(a).  Moreover, any cosmetic claims must appear outside the Drug Facts box.

Attachment:  Hand Lotion Containing 25% Dimethicone

Note: Font, font size, and font attributes (e.g., bold) shown above comply with Drug Facts format specifications in 21 CFR 201.66. 

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Date created: August 12, 2008

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