Product Assessment Against Criteria: Diaper Rash Products

Classification: Drug
Date of Decision: Spring 2009

Summary of Classification:

Diaper rash is recognized as an abnormal state of the skin requiring therapeutic intervention. As such, any product claiming treatment or prevention of diaper rash will be classified as a drug.

Evaluation Against Criteria

Representation:

Is the product represented in a manner suggesting it is used for treating, diagnosing, preventing, or curing disease or restoring, correcting or modifying organic functions in human beings?

A diaper rash, also known as irritant diaper dermatitis, is characterized by erythema and scaling of the skin in the diaper area, and can occur in children and adults. It develops when the stratum corneum breaks down as a result of exposure to prolonged wetness and an increased skin pH caused by urine and feces. In adults, the stratum corneum is composed of 25 to 30 layers of flattened dead keratinocytes, which are continuously shed and replaced from below. These dead cells are interlayed with lipids secreted by the stratum granulosum just underneath, which help to make this layer of the skin a waterproof barrier. The stratum corneum's function is to reduce water loss, repel water, protect deeper layers of the skin from injury and repel microbial invasion of the skin. In infants, this layer of the skin is much thinner and more easily disrupted. Diaper dermatitis can be complicated by secondary bacterial or fungal infection, or can be the result of seborrheic and/or atopic dermatitis.

Is the product likely to be understood by consumers to have characteristics of a drug?

Diaper rash creams are used solely for the prevention or treatment of an abnormal skin state and/or the alleviation of the resultant. Diaper rash products are not used for aesthetic or cosmetic purposes.

Composition:

Does the product's composition suggest it is an agent for treating, diagnosing, preventing, or curing disease or restoring correcting or modifying organic functions in human beings?

Diaper rash products contain ingredients frequently used in cosmetic as colourants or humectants (e.g. zinc oxide, allantoin, petrolatum, etc.) The ingredients in the products are not necessarily therapeutic until applied at appropriate concentrations and with the intent to treat or prevent an abnormal skin state such as diaper dermatitis or other medical condition.

Level of action:

Does the product exert solely a superficial effect?

The product is applied topically with no evidence of percutaneous absorption. The effect of the product is to treat and remove an abnormal and irritated skin condition, so its effect cannot be considered transient.

Other considerations:

In the United States, New Zealand, and Australia diaper rash products are classified as drugs. In the European Union, they are either cosmetics or drugs depending on whether a therapeutic treatment claim is made.

Conclusion:

The primary purpose of diaper rash products is to treat and prevent an abnormal skin condition which can result in infection and scarring if not treated properly. Based on these factors, diaper rash products meet the definition of 'drug' under the Food and Drugs Act, and are regulated under the Natural Health Product Regulations or Food and Drug Regulations depending on ingredient.

References:

  • Arad A, Mimouni D, Ben Amitai D, Zeharia A, and Mimouni M. "Efficacy of topical applications of eosin compared with zinc oxide paste and corticosteroid cream for diaper dermatitis." Dermatology 199 vol 4 (1999): 319-22.
  • Atherton D. "Maintaining healthy skin in infancy using prevention of irritant napkin dermatitis as a model." Community-Practitioner 78 vol 7 (Jul 2005): 255-7.
  • Canadian Pharmaceutical Association . Self-Medication: Reference for Health Professionals Vol.1, 4th Edition. Ottawa: Canadian Pharmaceutical Association, 1992.
  • EMEA. Borderline Between Directive 98/8/EC Concerning the Placing on the market of Biocidal Product and Directive 76/768/EEC Concerning Cosmetic Products. May 24, 2004.
  • FDA. Is It a Cosmetic, Drug, or Both (Or Is It Soap?). Washington: USA Department of Health and Human Services, July 8, 2002.
  • FDA. Skin Protectant Products for Over-the-Counter Human Use, Final Monograph 21 CFR Part 347. Washington: USA Department of Health and Human Services, 2003.
  • Fields S. "Wiping out diaper rash." International Journal of Pharmaceutical Compounding 9 Vol 6 (2005): 433-34.
  • Friel JB, ed. Dorland's Illustrated Medical Dictionary 26th edition. Toronto: WB Saunders, 1985.
  • Health Canada. Category IV Monograph: Medicated Skin Care Products. Ottawa: Therapeutic Products Directorate, September 11, 1995.
  • Health Canada. Diaper Rash Products. Ottawa: Therapeutic Products Directorate and Natural Health Products Directorate, April 19, 2007.
  • Hoggarth A, Waring M, Alexander J, Greenwood A, and Callaghan T. "A controlled, three-part trial to investigate the barrier function and skin hydration properties of six skin protectants." Ostomy Wound-Management 51 no.12 (Dec 2005): 30-42.
  • Kuller JM. "Skin breakdown: risk factors, prevention, and treatment". Newborn-and-Infant Nursing Reviews 1 vol 1 (Mar 2001): 35-42.
  • Mainstone A. "Maintaining infant skin health and hygiene." British Journal of Midwifery 13 vol 1 (Jan 2005): 44-7.
  • MHRA. A Guide to What is a Medicinal Product, MHRA Guidance Note No. 8. London: MHRA, amended April 2003.
  • MHRA. Borderline Products. London: MHRA, modified June 5, 2006
  • Morris JM. "The pharmacist's role in diaper dermatitis." America's Pharmacist 127 vol 10 (2005): 79-83.
  • NICNAS. Regulation of Cosmetic Chemicals: Final Report and Recommendation. Australia: Commonwealth of Australia, November 2005.
  • Nathwani D. "Nappy rash: a practical overview." Professional-Care-of-Mother-and-Child 11 vol 4 (2001): 100-2.
  • Sweetman SC, editor. Martindale: The Complete Drug Reference 33rd edition. Grayslake (IL): Pharmaceutical Press, 2002.
  • TGA. Draft Review of the Regulation of Products at the Interface Between Cosmetics and Therapeutic Goods. Australia: Commonwealth of Australia, January 16, 2005.
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