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Drugs and Health Products

Diaper Rash Products

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAss) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

April 19, 2007

Diaper rash products are classified as natural 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 at:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/form/index_e.html

Diaper rash products are classified as drugs if they contain at least one ingredient at a concentration listed in Table 2 (these ingredients must be declared as medicinal), and make a claim that the product is intended for prevention of diaper rash, protection from wetness that causes diaper rash, protection of chafed skin or temporary relief of minor skin irritation caused by diaper rash.
Applicants applying for a drug identification number (DIN) can access the appropriate forms and guidance at:
http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index_e.html

Table 1: NHP medicinal ingredients3
Proper name(s) Common name(s) Source material(s) Quantity

Table 1 Footnotes

Table 1 Footnote 1

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.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

The CAS number may be provided as additional information.

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

See Permitted combinations.

Return to Table 1 footnote3 referrer

Table 1 Footnote 4

Note that 1-40% zinc oxide is permitted in ointment dosage form, e.g. petrolatum based preparation. See introductory note at the beginning of the monograph for clarification on product classification.

Return to Table 1 footnote4 referrer

Allantoin
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)
Allantoin
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)

(2,5-Dioxo-4-imidazolidinyl) urea
(USP 30; O'Neil et al. 2001)

Glyoxyldiureide
(Sweetman 2007; Gottschalck and McEwen 2006; O'Neil et al. 2001)

5-Ureidohydantoin
(Sweetman 2007; Gottschalck and McEwen 2006; O'Neil et al. 2001)

Allantoin1
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001) CAS No. 000097-59-62
0.5-2%
(FDA 1990)
Calamine
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006)
Calamine
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006)
Calamine1
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006) CAS No. 008011-96-92
1-25%
(FDA 1990)
Cod liver oil3
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)
Cod liver oil
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)
Cod liver (Gadus morhua L. (Gadidae) and other species of Gadidae liver)
(Sweetman 2007; USP 30; O'Neil et al. 2001) CAS No. 008001-69-22
5-14%3
(FDA 1990)
Corn starch/Topical starch
(NF 25; Sweetman 2007; USP 30; Gottschalck and McEwen 2006)
Corn starch/Topical starch
(NF 25; Sweetman 2007; USP 30; Gottschalck and McEwen 2006)
Corn kernel
(Zea mays L. (Poaceae) kernel)

(USP 30)
10-98%
(FDA 1990)
Kaolin3
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)
Kaolin
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)

Argilla
(O'Neil et al. 2001)

Bolus alba
(Sweetman 2007; Gottschalck and McEwen 2006; O'Neil et al. 2001)

China clay
(Gottschalck and McEwen 2006; O'Neil et al. 2001)

Hydrated aluminum silicate
(Sweetman 2007; USP 30; O'Neil et al. 2001)

Porcelain clay
(O'Neil et al. 2001)

White bole
(O'Neil et al. 2001)
Kaolin1
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001) CAS No. 001332-58-72
4-20%
(FDA 1990)
Lanolin3
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)
Lanolin
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)

Wool fat
(Sweetman 2007; Gottschalck and McEwen 2006; O'Neil et al. 2001)

Sheep wool (Ovis aries L. (Bovidae) wool)
(Sweetman 2007; USP 30; O'Neil et al. 2001) CAS No. 008006-54-02
15.5%
(FDA 1990)
Talc
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)
Talc
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001)

Talcum
(Sweetman 2007; O'Neil et al. 2001)

Talc1
(Sweetman 2007; USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001) CAS No. 14807-96-62
45-100%
(FDA 1990)
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)
Zinc oxide1
(USP 30; Gottschalck and McEwen 2006; O'Neil et al. 2001) CAS No. 001314-13-22
1-25%4
(FDA 1990)
Table 2: Drug medicinal ingredients
Medicinal ingredient
preferred name
Quantity
Dimethicone 1-30%
Mineral oil 50-100%
Petrolatum 30-100%
White petrolatum 30-100%

Route(s) of administration

Topical (FDA 1990)

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 all products:

  • Helps prevent diaper rash (FDA 1990).
  • Protects chafed skin (or minor skin irritation) due to diaper rash (FDA 1990).
  • Helps protect from wetness that causes diaper rash (FDA 1990).
  • Temporarily helps relieve minor skin irritation due to diaper rash (FDA 1990).
For products containing calamine, corn starch, kaolin, talc and/or zinc oxide: Helps treat diaper rash (FDA 1990).

Dose(s)

Subpopulation(s)

Subpopulation does not need to be specified.

Quantity(ies)

See Tables 1 and 2 above.

Permitted combinations:

  • Cod liver oil and lanolin are not allowed as single medicinal ingredients (FDA 1990).
  • Any combination of the ingredients listed in Table 1 and/or 2 is permitted provided each ingredient in the combination is within the specified quantity (FDA 1990).

Directions for use:

Statement(s) to the effect of

For all products:
Apply liberally to a clean and dry diaper area as needed (FDA 1990).

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.
  • Avoid contact with eyes.
  • Consult a healthcare practitioner if symptoms worsen or last for more than 7 days (Berardi et al. 2002).
For all powder products:
  • Keep out of reach of children (FDA 1990).
  • Keep powder away from face to avoid inhalation, which can cause breathing problems (FDA 1990).
  • Not intended for use on broken skin (FDA 1990).

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 NNHPD 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 NNHPD 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, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • FDA 1990: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 347. Next link will take you to another Web site Skin Protectant Drug Products for Over-the Counter Human Use, Proposed Rulemaking for Diaper Rash Drug Products; 1990. [Accessed 2007-03-20].
  • Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook, 11th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2006.
  • 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, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc; 2001.
  • Sweetman SC, editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
  • USP 30: United States Pharmacopeia and the National Formulary (USP 30/NF 25). Rockville (MD): The United States Pharmacopeial Convention, Inc.; 2007.