Skin-Cap（适今可）到底怎么样

求答案

10几年前本人用过。经验告诉我们这类药物尽量少用为好。

http://www.yxb365.com/bbs/dispbbs.asp?boardid=12&Id=53477&page=4

下面的信息是2011年3月18号的，英文好的不妨翻译出来给大家看看。

刚才用谷歌翻译看了看，大致是说美国FDA发现“Skin Cap”中含有“丙酸氯倍他索”，但在说明书上并未标明，在不知情的情况下长期使用可能会产生副作用。

http://www.accessdata.fda.gov/cms_ia/importalert_165.html



Import Alert # 61-06
ublished Date: 03/18/2011
Type: DWPE Import Alert Name:

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

Reason for Alert:
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.

soriasis 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.

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

Guidance:
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) 796-5992.

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 Robert Eshelman of CDER's Division of Labeling and Non Prescription Compliance.

求翻译达人