FDA MedWatch - Skin-Cap Aerosol Spray Products by Chemigroup France

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TOPIC: Skin-Cap Aerosol Spray Products by Chemigroup France: CDER Alert - Do Not Purchase or Use Because They May Be Harmful to Your Health

AUDIENCE: Consumer, Health Care Professional, Dermatology

ISSUE: FDA is warning consumers to not purchase or use Skin-Cap aerosol spray products because they may contain undisclosed steroids. This product, sold by Chemigroup France, formerly known as Cheminova Laboratories, has been found for sale on skincap.com, amazon.com, and walmart.com.

FDA testing identified a high-potency glucocorticosteroid (immunosuppressive and anti-inflammatory drugs) in Skin-Cap aerosol spray products that is not disclosed on the label or packaging.

Long-term use of topical corticosteroids, like glucocorticosteroids can cause health problems such as skin thinning (atrophy) and skin reactions, and if used on large body areas may lead to increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and changes in hormone levels (adrenal dysfunction).

FDA is not currently aware of any adverse events related to Skin-Cap aerosol spray products.

For more information about this alert, click on the red button "Read Alert" below.

BACKGROUND: Skin-Cap Aerosol Spray products are marketed as a treatment for psoriasis, seborrheic, dermatitis and typical eczema, painful lichen, skin redness, dandruff, itching and irritation of the skin.

RECOMMENDATIONS: 

• Consumers using this product should contact their health care professional to determine the best course of action. Abruptly stopping the use of this product may cause adverse reactions.

Health care professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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