Import Alert 61-06

"Detention Without Physical Examination of Skin Cap Spray, Shampoo And Cream"

Skin Cap, an over the counter (OTC) drug for psoriasis was found by FDA analysis to contain prescription levels of a potent medication, the topical steroid, clobetasol propionate, which can cause serious side effects if used incorrectly or unknowingly. Users would be unaware of the presence of this ingredient, as it is not declared on the labeling for the products. Side effects from long term use of potent topical steroids can include stretch marks, thinning skin, and tiny dilated blood vessels. Use of large amounts, overuse or long term use of potent topical steroids can also cause more serious side effects.

Skin Cap is an over the counter (OTC) drug sold in various forms (spray, cream, shampoo) that is manufactured by Cheminova International Laboratories, Madrid, Spain, and is available through several U.S. distributors.

Psoriasis is a chronic skin disorder that can be painful and disabling. It is characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce six times faster than normal skin cells.

According to Cheminova International, the active ingredient in Skin Cap is zinc pyrithione (ZnP). ZnP is the same active ingredient found in some dandruff shampoos, for which there is no history as an effective psoriasis treatment. Zinc pyrithione (ZnP) has never been found safe and effective for the treatment of psoriasis. ZnP is acceptable as an OTC product for the treatment of seborrheic dermatitis and dandruff only.

FDA has attempted to inspect the manufacturer and ***contract manufacturer*** to determine compliance with regard to ingredients used in the production of all their products. The firms have not permitted FDA inspections, therefore, we are unable to assure manufacturing operations are in compliance and that the use of clobetasol propionate has not extended to other products manufactured/repacked by these firms.

Products from these facilities may contain a undeclared prescription strength corticosteroid (clobetasol propionate), although the labeling bears the active ingredient zinc pyrithione.

All products manufactured by Cheminova and all products repacked for Cheminova by Aerosoles Preval may be detained without physical examination based on the refusal of Cheminova Internacionale and Aerosoles Preval to permit FDA inspection of their Madrid, Spain facilities.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

When a shipment of product is detained without physical examination, and the importer submits samples to a private laboratory for analysis, if private laboratory analysis DOES NOT INDICATE the presence of clobetasol proprionate, please contact
***the CDER/Office of Compliance (OC), Imports Exports Compliance Branch. The CDER/OC/Imports Exports Compliance Branch can be contacted at cderimportsexports@fda.hhs.gov***

All drug products

"This article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]."

OASIS charge code - UNAPPROVED

"The products appear to be adulterated as the firm has a history of contamination which may indicate the methods used in, or the facilities or controls used for, its manufacture, do not conform to or are not operated in conformity with current good manufacturing practice [501(a)(2)(B)]."

OASIS charge code - DRUG GMPS