Medicated Skin Care Products

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Date: March 30, 2007

Medicated skin care products are classified as natural

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health products (NHPs) if they contain ingredients from Table 1 only. Applicants applying for a natural product number (NPN) can access the appropriate forms and guidance.

Medicated skin care products are classified as drugs if they contain at least one ingredient from Table 2. Applicants applying for a drug identification number (DIN) can access the appropriate forms and guidance.

Table 1: NHP medicinal ingredients

Proper name(s)	Common name(s)	Source material(s)	Quantity
Allantoin1 (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Allantoin (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) (2,5-Dioxo-4-imidazolidinyl) urea (USP 30; O'Neil et al.2001) Glyoxyldiureide (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) 5-Ureidohydantoin (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Allantoin* (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) CAS No. 000097-59-6+	0.5-2% (FDA 2003)
Almond oil (NF 25; Sweetman 2002)	Almond oil (NF 25; Sweetman 2002)	Almond kernel (sweet almond oil from Prunus dulcis (Mill.) D.A. Webb (Rosaceae) kernel) (NF 25; Leung and Foster 2003)	≤ 100% (Leung and Foster 2003)
Aluminum hydroxide gel1 (USP 30; Sweetman 2002; O'Neil et al.2001)	Aluminum hydroxide gel (USP 30; Sweetman 2002; O'Neil et al.2001) Aluminum hydrate gel (Gottschalck and McEwen 2006; O'Neil et al.2001)	Aluminum hydroxide gel* (USP 30; Sweetman 2002; O'Neil et al.2001) CAS No. 021645-51-2+	0.15-5% (FDA 2003)
Calamine1 (USP 30; Gottschalck and McEwen 2006; Sweetman 2002)	Calamine (USP 30; Gottschalck and McEwen 2006; Sweetman 2002)	Calamine* (USP 30; Gottschalck and McEwen 2006; Sweetman 2002) CAS No. 008011-96-9+	1-25% (FDA 2003)
Cocoa butter1 (NF 25; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Cocoa butter (NF 25; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) Cocao butter Gottschalck and McEwen 2006; Sweetman 2002) Theobroma oil (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Cocoa seed (Theobroma cacao L. (Malvaceae) roasted seed) (NF 25; Sweetman 2002; O'Neil et al.2001) CAS No. 008002-31-1+	50-100% (FDA 2003)
Cod liver oil1 (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Cod liver oil (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Cod liver (Gadus morhua L. (Gadidae) and other species of Gadidae liver) (USP 30; Sweetman 2002; O'Neil et al.2001) CAS No. 008001-69-2+	5-14% 1 (FDA 2003)
Colloidal oatmeal1 (USP 30; Gottschalck and McEwen 2006; Sweetman 2002)	Colloidal oatmeal (USP 30; Gottschalck and McEwen 2006; Sweetman 2002)	Oat kernel (Avena sativa L. (Poaceae) kernel) (USP 30; Sweetman 2002)	1-100% (FDA 2003)
Corn starch/Topical starch1 (NF 25; USP 30; Gottschalck and McEwen 2006; Sweetman 2002)	Corn starch/Topical starch (NF 25; USP 30; Gottschalck and McEwen 2006; Sweetman 2002)	Corn kernel (Zea mays L. (Poaceae) kernel) (USP 30)	10-98% (FDA 2003)
Glycerine/glycerol1 (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001)	Glycerine/glycerol (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001)	Glycerine* (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001) CAS No. 000056-81-5+	20-45% (FDA 2003)
Hard fat1 (NF 25; Sweetman 2002)	Hard fat (NF 25; Sweetman 2002)	Hard fat* (NF 25; Sweetman 2002)	50-100% (FDA 2003)
Kaolin1 (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Kaolin (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) Argilla (O'Neil et al.2001) Bolus alba (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) China clay (Gottschalck and McEwen 2006; O'Neil et al.2001) Hydrated aluminum silicate (USP 30; Sweetman 2002; O'Neil et al.2001) Porcelain clay (O'Neil et al.2001) White bole (O'Neil et al.2001)	Kaolin* (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) CAS No. 001332-58-7+	4-20% (FDA 2003)
Lactic acid (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001) DL-Lactic acid (O'Neil et al.2001) 2-Hydroxypropanoic acid (USP 30; O'Neil et al.2001)	Lactic acid (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001)	Lactic acid* (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001) CAS No. 000050-21-5+	2-5% (Berardi et al.2002)
Lanolin1 (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Lanolin (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) Wool fat (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Sheep wool (Ovis aries L. (Bovidae) wool) (USP 30; Sweetman 2002; O'Neil et al.2001) CAS No. 008006-54-0+	12.5-50% (FDA 2003)
Olive oil (NF 25; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Olive oil (NF 25; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Olive (Olea europaea L. (Oleaceae) fruit) (NF 25; Sweetman 2002; O'Neil et al.2001)	≤ 100% (Sweetman 2002)
Sodium bicarbonate (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Sodium bicarbonate (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) Baking soda (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) Carbonic acid monosodium salt (USP 30; Gottschalck and McEwen 2006) Sodium hydrogen carbonate (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Sodium bicarbonate* (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) CAS No. 000144-55-8+	1-100% (FDA 2003)
Urea (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Urea (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) Carbamide (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Urea* (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) CAS No. 000057-13-6+	10% (Berardi et al.2002)
Zinc acetate1 (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001)	Zinc acetate (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) Acetic acid, zinc salt (Gottschalck and McEwen 2006)	Zinc acetate* (USP 30; Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al.2001) CAS No. 000557-34-6+	0.1-2% (FDA 2003)
Zinc carbonate1 (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001)	Zinc carbonate (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001)	Zinc carbonate* (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001) CAS No. 003486-35-9+	0.2-2% (FDA 2003)
Zinc oxide1 (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001)	Zinc oxide (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001)	Zinc oxide* (USP 30; Gottschalck and McEwen 2006; O'Neil et al.2001) CAS No. 001314-13-2+	1-25% zinc oxide (FDA 2003) 1-40% zinc oxide ointment (FDA 1990)

* Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Compendium of Monographs Guidance Document) or requires citation of an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.
⁺ The CAS number may be provided as additional information.
¹ See Permitted combinations.

Table 2: Drug medicinal ingredients

Medicinal ingredient preferred name	Quantity
Dimethicone	1-30%
Mineral oil1	50-100%; 30-35% when in combination with colloidal oatmeal
Petrolatum1	30-100%
White petrolatum1	30-100%

¹ See Permitted combinations.

Route(s) of administration: Topical (FDA 2003)

Dosage form(s): Those that are suited to the allowable route of administration and are established, scientifically recognized dosage forms.

Use(s) or purpose(s): Statement(s) to the effect of:

For products containing almond oil, corn starch, dimethicone, glycerine, lactic acid, olive oil or urea:

• Temporarily protects and helps relieve minor skin irritation and itching (Berardi etal. 2002).

For products containing allantoin, cocoa butter, cod liver oil, hard fat, lanolin, mineral oil, petrolatum and/or white petrolatum:

• Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns (FDA 2003).

For products containing aluminum hydroxide gel, calamine, kaolin, zinc acetate, zinc carbonate and/or zinc oxide:

• Dries the oozing and weeping and helps relieve minor skin irritation and itching due to poison ivy, poison oak and poison sumac (FDA 2003).

For products containing colloidal oatmeal:

• Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, poison oak or poison sumac, and insect bites (FDA 2003).

For products containing sodium bicarbonate:

• Temporarily protects and helps relieve minor skin irritation and itching due to poison ivy, poison oak or poison sumac, and insect bites (FDA 2003).

For products containing colloidal oatmeal and mineral oil in combination:

• Temporarily protects and helps relieve minor skin irritation and itching due to rashes or eczema (FDA 2003).

Note: Product labels must contain at least one of the above health claims. Claims that are cosmetic in nature such as "relieves dry skin" or "protects against and alleviates chapping, cracking and roughness due to dryness" are acceptable as additional information, provided that the claims are true and verifiable.

Dose(s):

Subpopulation: Subpopulation does not need to be specified.

Quantity: See Tables 1 and 2 above.

Permitted combinations:

• Cod liver oil is not allowed as a single medicinal ingredient (FDA 2003).
• Any two or more of the following ingredients may be combined, provided each ingredient in the combination is within the concentration specified above: allantoin, cocoa butter, cod liver oil, glycerine, hard fat, lanolin, mineral oil, petrolatum, and white petrolatum (FDA 2003).
• Any two or more of the following ingredients may be combined, provided each ingredient in the combination is within the concentration specified above: aluminum hydroxide gel, calamine, kaolin, zinc acetate, zinc carbonate, and zinc oxide (FDA 2003).
• Colloidal oatmeal and mineral oil may be combined provided each ingredient in the combination is within the concentration specified above (FDA 2003).

Directions for use: Statement(s) to the effect of:

For all products, excluding colloidal oatmeal products, that are used as a soak in a bath, as a compress or as a wet dressing, and sodium bicarbonate products used as a paste, a soak in a bath, a compress or wet dressing:
Apply to affected area as needed (FDA 2003).

For colloidal oatmeal products used as a soak in a bath:

1. Using warm water turned on at full force, slowly sprinkle (applicant to insert quantity to be used) under running water (FDA 2003).
   (Applicant must provide adequate directions to allow consumers to obtain a solution containing:
   • For tub bath/infant bath−a minimum of 0.007% colloidal oatmeal or 0.003% colloidal oatmeal when in combination with mineral oil;
   • For foot bath−a minimum of 0.25% colloidal oatmeal.)
2. Stir thoroughly to prevent clumping and settling (FDA 2003).
3. Soak affected area for 15 to 30 minutes as needed or as directed by a health care practitioner (FDA 2003).
4. Pat dry (do not rub) to keep a thin layer on the skin (FDA 2003).

For colloidal oatmeal products used as a compress or wet dressing:

1. Using warm water turned on at full force, slowly sprinkle (applicant to insert quantity to be used) under running water (FDA 2003).
   (Applicant must provide adequate directions to allow consumers to obtain a solution containing a minimum of 0.25% colloidal oatmeal.)
2. Stir thoroughly to prevent clumping and settling (FDA 2003).
3. Soak a clean, soft cloth in the mixture (FDA 2003).
4. Apply cloth loosely to affected area for 15 to 30 minutes (FDA 2003).
5. Repeat as needed or as directed by a health care practitioner (FDA 2003).
6. Discard mixture after each use (FDA 2003).

For sodium bicarbonate products used as a paste:

1. Add water to form a paste (FDA 2003).
2. Apply to affected area as needed or as directed by a health care practitioner (FDA 2003).

For sodium bicarbonate products used as a soak in a bath:

1. Dissolve 250 to 500 ml (1 to 2 cupfuls) in a tub of warm water (FDA 2003).
2. Soak for 10 to 30 minutes as needed or as directed by a health care practitioner (FDA 2003).
3. Pat dry (do not rub) to keep a thin layer on the skin (FDA 2003).

For sodium bicarbonate products used as a compress or wet dressing:

1. Add to water to make a mixture in a container (FDA 2003).
2. Soak a clean, soft cloth in the mixture (FDA 2003).
3. Apply cloth loosely to affected area for 15 to 30 minutes (FDA 2003).
4. Repeat as needed or as directed by a health care practitioner (FDA 2003).
5. Discard mixture after each use (FDA 2003).

Duration of use: No statement is required.

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s):

For all products:

• For external use only (FDA 2003).
• Avoid contact with eyes (FDA 2003).
• Consult a healthcare practitioner if symptoms worsen or last for more than 7 days (FDA 2003).

For products containing colloidal oatmeal or sodium bicarbonate (when labelled for use as a soak, compress or wet dressing):

• When using this product in some skin conditions, soaking too long may over-dry the skin (FDA 2003).

For products containing glycerine or aluminum hydroxide gel:

• Consult a health care practitioner prior to use on children less than 6 months of age (FDA 2003).

For products containing zinc acetate or sodium bicarbonate:

• Consult a health care practitioner prior to use on children less than 2 years of age (FDA 2003).

For all products containing alpha-hydroxy acids (AHA) at concentrations ranging from 3-10% and/or retinol at concentrations ranging from 0.1-1.0%:

• "This product contains [insert as appropriate: an alpha-hydroxy acid (AHA) and/or retinol] which may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Limit sun exposure and apply a sunburn protectant while using this product and for a week afterwards."

A non-exhaustive list of AHAs is as follows:
Citric acid (CAS No. 77-92-9), glycolic acid (CAS No. 79-14-1), lactic acid (CAS No. 50-21-5), malic acid (CAS No. 6915-15-7), glycolic acid + ammonium glycolate, alpha-hydroxyethanoic acid + ammonium alpha-hydroxyethanoate, alpha-hydroxyoctanoic acid, alpha-hydroxycaprylic acid, hydroxycaprylic acid, mixed fruit acid, triple fruit acid, tri-alpha hydroxy fruit acids, alpha hydroxy and botanical complex, L-alpha hydroxy acid and glycomer in cross-linked fatty acids alpha nutrium.

For all powder products:

• Keep powder away from face to avoid inhalation, which can cause breathing problems (FDA 2003).
• Not intended for use on broken skin (FDA 2003).

For products marketed to temporarily protect minor cuts, scrapes and/or burns:

• Not intended for use on deep or puncture wounds, animal bites or serious burns (FDA 2003).

Contraindication(s): No reports known.

Known adverse reaction(s): No reports known.

Non-medicinal ingredients: The International Nomenclature for Cosmetic Ingredients (INCI) will be accepted.

For products containing Table 1 medicinal ingredients only:

• Ingredients must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
• Other ingredients currently accepted as cosmetic ingredients will also be considered.

Specifications: This monograph describes those requirements that are specific to this class of drugs and to natural health products (NHPs). Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the monograph.

Note that for products containing Table 1 NHP medicinal ingredients only:

• Products must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.

For products containing Table 2 drug medicinal ingredients:

• Requirements described in the Regulations to the Food and Drugs Act must be met.

References:

Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13^th edition. Washington (DC): American Pharmaceutical Association; 2002.

FDA 2003: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 347. Skin protectant products for Over-the-Counter Human Use, Final Monograph; 2003. [Accessed 2007-03-14]. Available at: http://www.fda.gov/cder/otcmonographs/Skin_Protectant/
skin_protectant_FM_20030604.pdf

FDA 1990: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 347. Skin Protectant Drug Products for Over-the Counter Human Use, Proposed Rulemaking for Diaper Rash Drug Products; 1990. [Accessed 2007-03-14]. Available at: http://www.fda.gov/cder/otcmonographs/Skin_Protectant/
skin_protectant_diaper_rash_PR_19900620.pdf

Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook, 11^th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2006.

Leung AY, Foster S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs, and Cosmetics, 2^nd edition. Hoboken (NJ): John Wiley and Sons, Inc.; 2003.

NF 25: United States Pharmacopeia and the National Formulary (USP 30/NF 25). Rockville (MD): The United States Pharmacopeial Convention, Inc.; 2007.

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13^th edition. Whitehouse Station (NJ): Merck & Co., Inc; 2001.

Sweetman SC, editor. Martindale: The Complete Drug Reference, 33^rd edition. Grayslake (IL): Pharmaceutical Press; 2002.

USP 30: United States Pharmacopeia and the National Formulary (USP 30/NF 25). Rockville (MD): The United States Pharmacopeial Convention, Inc.; 2007.