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Drugs and Health Products

Corn & Callus Remover

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) 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 26, 2006

Medicinal ingredients

Proper name(s) Common name(s) Source material(s)

Table 1 Footnotes

Table 1 Footnote 1

Ingredient must be of pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Compendium of Monographs.) 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 footnote * referrer

Table 1 Footnote 2

The CAS number may be provided as additional information.

Return to Table 1 footnote + referrer

Table 1 Footnote 3

Note: Optional pharmacopoeial standard formulations are shown in Appendix 1.

Salicylic acid
(Gottschalck & McEwen 2004; USP 29; O'Neil et al.2001)

2-hydroxybenzoic acid
(Gottschalck & McEwen2004; O'Neil et al. 2001)
Salicylic acid
(Gottschalck & McEwen 2004; USP 29; O'Neil et al.2001)
Salicylic acidTable 1 Footnote *
(Gottschalck & McEwen 2004; USP 29; O'Neil et al. 2001)
CAS No. [000069-72-7]Table 1 Footnote +

Route(s) of administration

Topical (FDA 1990)

Dosage form(s)

Plaster or collodion-like solution (FDA 1990)

Use(s) or Purpose(s)

Statement to the effect of

For the removal of corns and calluses (FDA 1990)

Dose(s)

Subpopulation(s)

Subpopulation does not need to be specified.

Quantity

Salicylic acid: 12 - 40 % in a plaster (FDA 1990)

Salicylic acid: 12 - 17.6 % in a collodion-like solution (FDA 1990)

Directions for use

Statement(s) to the effect of

For products formulated in a plaster (FDA 1990):
  1. Wash affected area and dry thoroughly.
  2. Cut plaster to fit corn/callus (if appropriate).
  3. Apply medicated plaster.
  4. After 2 days remove the medicated plaster.
  5. Repeat this procedure every 2 days as needed (until corn/callus is removed) for up to 14 days.
  6. Optional: To assist in removal of the corn/callus, at the end of the treatment period soak in warm water for 5 minutes.
For products formulated in a collodion-like solution (FDA 1990):
  1. Wash affected area and dry thoroughly.
  2. With applicator/brush, apply a small amount to sufficiently cover each corn/callus. Let dry.
  3. Repeat this procedure once or twice daily as needed (until corn/callus is removed) for up to 14 days.
  4. Optional: To assist in removal of the corn/callus, at the end of the treatment period soak in warm water for 5 minutes.

Duration of use

Use for up to 14 days (FDA 1990).

Risk information

Statement(s) to the effect of

Cautions and warnings

For all products:
  • For external use only (FDA 1990).
  • Consult a health care practitioner if discomfort persists (FDA 1990).
For products formulated in a collodion-like solution only:
  • Extremely flammable or flammable or combustible (FDA 1990).
  • Keep away from fire or flame (FDA 1990).
  • Cap bottle tightly and store at room temperature away from heat (FDA 1990).
  • If product gets into the eye, flush with water for 15 minutes (FDA 1990).
  • Avoid inhaling vapours (FDA 1990).

Contraindications

For all products:
  • Do not use on irritated or reddened skin or any area that is infected (FDA 1990).
  • Do not use if you have diabetes or poor blood circulation (FDA 1990).

Optional label information

For products which contain cushions the following additional information may be included on the product label:

"(Protective) Cushion helps to relieve painful shoe pressure."

Non-medicinal ingredients

Must be chosen from the current List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications

Must comply with the minimum specifications outlined in the current Compendium of Monographs..

References

  • BP 2003: The British Pharmacopoeia Commission. London (UK): Her Majesty's Stationary Office; 2003
  • FDA 1990: The USA Department of Health and Human Services: Food and Drug Administration. 55 CFR Part 157. Next link will take you to another Web site Corn and Callus Remover Drug Products for Over-the-Counter Human Use, Final Monograph; 1990. [accessed 2006-01-09].
  • Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook, 10th ed. Washington (D.C.):Cosmetic, Toiletry and Fragrance Association; 2004.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, & Biologicals, 13th ed. Whitehouse Station (NJ): Merck & Co., Inc; 2001.
  • USP 29: The United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.

Appendix 1

Formulation USP 29 BP 2003
Salicylic acid collodion X X
Salicylic acid plaster X -