Save Skin Cap

All the information regarding the SKIN CAP controversy

August 11, 1997 

Dear Dermatologists 

As the innovater of  TEMOVATE brand clobetasol propionate and your partner in dermatological care, Glaxo Dermatology is providing you with the following important information about a product called Skin Cap.  Based on an analysis of Skin Cap spray conducted by Glaxo Dermatology and an independant laboratory, we have determined the presence of clobetasol propionate in three lots of product analyzed.  Clobetasol propionate, as you already know, is the active ingredient in TEMOVATE, a family of prescription super-high-potency corticosteroid products. 

Skin Cap is an over the counter product available via mail order that is labelled for use in seborrhaic dermatitis and dandruff.  skincap lists as its active ingredient Zinc Pyrithione, which is indicated in the FDA over the counter Monograph only for the treatment of dandruff and seborrhaic dermatitis.  However, it has been widely promoted for use in psoriasis and eczema in such publications as Skin And Allergy News and at the Spring and Summer Meetings of the American Academy of Dermatology.  Skin Cap spray shampoo and cream are manufactured by Laboratorios Cheminova International of Madrid, Spain, and distributed by Vilana/Cheminova America Corp of Miami,  Florida.  

Because of inquiries regarding Skin Cap and concern regarding the presence of steroids in the product, we are providing this information to dermatologists to help you advise your patients who have questions about this product.  As your partner in dermatological care, we are concerned about Skin Cap and we are in the process of notifying the FDA regarding our findings. 

TEMOVATE has been shown to provide proven efficacy and a favorable safety profile in numerous trials and in over 11 years of clinical use, when used appropriately.  As you know, TEMOVATE is a super-high-potency topical corticosteroid and should only be used under your supervision.  If you would like more information about the TEMOVATE family of products, please contact your Glaxo Dermatology Sales Representative. 

Signed, 
Paul Dryer 
Group Director of Sales and Marketing 
Glaxo Dermatology 

Treatment with TEMOVATE should be limited to 2 consecutive weeks and the total dosage should not exceed 50 grams per week because of the potential for temovate to suppress the hpa axis.  Temovate should not be used on the face, groin, or axillae or with occlusive dressings and is not recommended for children under 12 years of age. 

Please see complete prescribing information for TEMOVATE enclosed.