Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Hydrocortisone - Topical

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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 ingredient.

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

December 8, 2015

Proper name(s)

  • Hydrocortisone (O'Neil et al. 2001)
  • (11β)-11,17,21-trihydroxypregn-4-ene-3,20-dione (USP 37; O'Neil et al. 2001)

Common name(s)

  • Hydrocortisone (O'Neil et al. 2001)
  • Cortisol (O'Neil et al. 2001)
  • 17-hydroxycorticosterone (O'Neil et al. 2001)

Source material(s)

  • Hydrocortisone (O'Neil et al. 2001)
  • Hydrocortisone acetate (O'Neil et al. 2001)

Route(s) of administration

Topical

Dosage form(s)

Those pharmaceutical dosage forms suited to topical administration, excluding patches, poultices, dressings, pastes and plasters.

Use(s) or Purpose(s)

Statement(s) to the effect of
  • For temporary relief of:
    • minor skin irritations associated with redness, itching, dryness and scaling (HC 1985)
    • minor skin irritations, rashes, itching and redness due to eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (e.g. caused by soaps, detergents, cosmetics and/or jewellery), seborrheic dermatitis, psoriasis (FDA 1986, 1983)
    • (external) feminine, genital itching (FDA 1983)
    • (external) anal itching (due to hemorrhoids) (FDA 1983)
  • Anti-pruritic (FDA 1983)
  • Anti-itch (FDA 1983)

Dose(s)

Statement(s) to the effect of

Subpopulation(s)

Products for (external) feminine genital or anal itching
Adults and children 12 years and older (FDA 1990a, 1988, 1980)
All other products
Adults and children 2 years of age and older (FDA 1990b)

Quantity(ies)

0.5 - 1.0% Hydrocortisone (SC 1985, SC 2014)

Direction(s) for use

Statement(s) to the effect of
All products
Apply sparingly to affected area, not more than 3 to 4 times daily.
Products for anal itching
Gently cleanse, rinse thoroughly, and dry the affected area prior to application (FDA 1990a, 1988).

Duration of use

No statement required.

Risk information

Statement(s) to the effect of

Caution(s) and warning(s)

All products
  • For external use only (HC 1985).
  • If symptoms worsen or persist more than 7 days, or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless directed by a health care practitioner (FDA 1991; FDA 1990b; HC 1985).
Products for anal itching
In case of bleeding, consult a health care practitioner promptly (FDA 1990a, 1988).

Contraindication(s)

All products
  • Do not use in or around the eyes (HC 1985).
  • Do not apply to large areas (HC 1985).
  • Do not use on children 2 years of age or younger, except on the advice of a health care practitioner (HC 1985). (Statement not required for products for (external) feminine genital or anal itching.)
  • Do not use for the treatment of diaper rash, except on the advice of a health care practitioner (Berardi et al. 2002; FDA 1990b).
Products for (external) feminine genital itching
Do not use to treat vulvar itching associated with a vaginal discharge, except on the advice of a health care practitioner (HC 1985).

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID. In addition the medicinal ingredient may comply with the specifications outlined in the American (USP 37), European (Ph. Eur. 2013) Pharmacopoeias (Refer to Appendix 1, Table 1).

References cited

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.

Ph.Eur. 2013: European Pharmacopoeia. 8th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM); 2013.

FDA 1991: USA Department of Health and Human Services: Food and Drug Administration. Next link will take you to another Web site Hydrocortisone; Marketing Status as an External Analgesic Drug Product for Over-the-Counter Human Use; Notice of Enforcement Policy; 1991. [Accessed October 9, 2014].

FDA 1990a: USA Department of Health and Human Services: Food and Drug Administration. 55 CFR Part 346. Next link will take you to another Web site Anorectal Drug Products for Over-the-Counter Human Use; Final Monograph; 1990. [Accessed October 9, 2014].

FDA 1990b: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 348. Next link will take you to another Web site External Analgesic Drug Products for Over-the-Counter Human Use; Amendment of Tentative Final Monograph; 1990. [Accessed October 9, 2014].

FDA 1988: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 348. Next link will take you to another Web site External Analgesic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; 1988. [Accessed October 9, 2014].

FDA 1986: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 348. Next link will take you to another Web site External Analgesic Drug Products for Over-the-Counter Human Use; Amendment to Tentative Final Monograph; 1986. [Accessed October 9, 2014].

FDA 1983: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 348. Next link will take you to another Web site External Analgesic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; 1983. [Accessed October 9, 2014].

FDA 1980: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 346. Next link will take you to another Web site Anorectal Drug Products for Over-the-Counter Human Use: Establishment of a Monograph; 1980. [Accessed October 9, 2014].

Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook. 10th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2006.

HC 2014: Notice: Prescription Drug List (PDL): Next link will take you to another Web site Hydrocortisone. [Accessed October 9, 2014]

HC 1985: Health Canada. Information Letter No. 678, Recommendations of the Expert Advisory Committee on Dermatology Regarding the Availability of Over-the-Counter Topical Preparations Containing Hydrocortisone. Ottawa (ON): Health Canada; 1985.

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 and Co., Inc; 2001.

USP 37: United States Pharmacopeia and the National Formulary (USP 37/NF 32). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2013.

Appendix 1

Table 1: Optional pharmacopoeial formulations
Formulation USP 37 Ph.Eur. 2013
Hydrocortisone X X
Hydrocortisone Cream X
Hydrocortisone Gel X
Hydrocortisone Lotion X
Hydrocortisone Ointment X
Hydrocortisone Acetate X X
Hydrocortisone Acetate Cream X
Hydrocortisone Acetate Lotion X
Hydrocortisone Acetate Ointment X