CLA-2-30:RR:NC:2:238 B83221

Robert J. Leo, Esq.
Meeks & Sheppard
330 Madison Avenue, 39th Floor
New York, NY 10017

RE: The tariff classification of Nizoral? (ketoconazole) 2% Shampoo, put up in 4 fl. ounce plastic bottles, from Belgium

Dear Mr. Leo:

In your letter dated March 12, 1997, on behalf of your client, Janssen Pharmaceutica Inc., you requested a tariff classification ruling.

The submitted sample, Nizoral? (ketoconazole) 2% Shampoo, consists of a plastic bottle containing four fluid ounces of a red-orange liquid. The shampoo contains 2% ketoconazole (an antifungal drug), as the active ingredient, and, according to the product label, can only be dispensed by prescription. According to the Physician's Desk Reference (1997), the subject product is indicated for the reduction of scaling due to dandruff.

The applicable subheading for the subject product will be 3004.90.9010, Harmonized Tariff Schedule of the United States (HTS), which provides for: "Medicaments ... consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Anti-infective medicaments: Other." The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number (301) 443-6553.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Cornelius Reilly at 212-466-5770.

Sincerely,

Gwenn Klein Kirschner
Chief, Special Products Branch National Commodity Specialist Division