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COMBE OTC HYDROCORTISONE LABELING STATEMENTS PROMPT FDA WARNING LETTER

Executive Summary

COMBE OTC HYDROCORTISONE LABELING STATEMENTS PROMPT FDA WARNING LETTER Nov. 4 stating that claims for a total of eight Gynecort, Lanacort and Scalpicin 1% and .5% hydrocortisone external analgesic products are "not in accord with the required labeling." Product label statements cited by the agency include: "more complete relief and healing," "hypoallergenic," "with soothing aloe," and "calms the body's natural reaction to itch- causing disturbances and helps natural healing." The eight Combe products cited in the warning letter are Lanacort 10 and Lanacort 5 hydrocortisone 1% and .5%, respectively, in both ointment and cream formulations; Gynecort 10 and Gynecort 5 1% and .5% hydrocortisone cream; "Prescription Strength Scalpicin Anti-Itch & Scalp Relief Medicine"; and "Scalpicin Scalp Relief Medicine." "Because hydrocortisone 1% is an Rx-to-OTC switch...there can be no deviation from the required language" proposed in an OTC tentative final monograph, the warning letter states. That policy was detailed in a July 12, 1985 letter to Biocraft clarifying the agency's April 1985 "flexibility" policy. For Rx-to-OTC switches, "the exact wording of the proposed or tentative final monograph must be used until a final monograph is issued," the 1985 letter states. The warning letter to Combe adds that the firm's .5% hydrocortisone products are also "subject to regulatory action under...provisions...pertaining to the marketing of drugs containing active ingredients which have been permitted to switch from prescription-to-OTC human use." FDA announced it would allow the OTC marketing of strengths of hydrocortisone above .5% up to 1% in an Aug. 30, 1991 Federal Register notice. In response to the warning letter, Combe said it wrote FDA Nov. 19 to "discuss...the applicability of the FDA 'flexibility' policy for label claims to OTC hydrocortisone products." The company said it believes its labeling "language is truthful and non-misleading." The 1% hydrocortisone indication proposed in the 1990 amendment to the external analgesic TFM is "The temporary relief of itching associated with minor skin irritations, inflamation, and rashes due to [one or more of the following:] eczema, insect bites, poison ivy, poison oak, or poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and/or for external [select one or more:] genital, feminine and anal itching" ("The Pink Sheet" March 5, 1990, p. 3). Specific claims for "Prescription Strength Scalpicin" cited by FDA are "controls skin or scalp itching, irritation, redness, flaking, scaling,...to heal deep scalp itch..." and, for "Scalpicin Scalp Relief Medicine," "stops flakes from forming ...heal 'deep scalp itch'...'severe dandruff'...controls irritation and redness." The warning letter adds that the statements of identity, "Scalp Relief Medicine" and "Feminine Itch Relief Creme" (Gynecort 5), are not in conformance with the external analgesic TFM. The Nov. 4 warning letter, from Richard Chastonay, director of the drug labeling division, marks the second time Combe's OTC analgesic claims have elicited FDA scrutiny. In 1991, Combe received a warning letter for claims relating to yeast infection included in its Vagisil benzocaine/resorcin external analgesic labeling ("The Pink Sheet" July 1, 1991, T&G-13). Combe has taken out the specific reference to yeast infections in its labeling.
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