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NY L84784




May 13, 2005

CLA-2-30:RR:NC:2:238 L84784

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9145

Mr. Rodney Ralston
UPS Supply Chain Solutions
One UPS Way
Champlain, NY 12919

RE: The tariff classification of CEROVEL™ (40% Urea) Lotion, CEROVEL™ (40% Urea) Cream, and CEROVEL™ (40% Urea) Gel from Canada

Dear Mr. Ralston:

In your letter dated April 27, 2004, on behalf of your client, EZEM Canada Inc., you requested a tariff classification ruling. The samples you submitted are being returned as requested.

The three subject products, namely: CEROVEL™ (40% Urea) Lotion, CEROVEL™ (40% Urea) Cream, and CEROVEL™ (40% Urea) Gel, are medicaments containing 40% urea (by weight) as the active ingredient. All three products are dispensed by prescription only. CEROVEL™ Lotion is supplied in plastic bottles, each containing 11 fl oz (325 mL) of lotion. CEROVEL™ Cream is supplied in plastic tubes, each containing 4.5 oz (133 g) of cream. The plastic tube, in turn, is put up for retail sale in a paperboard box. CEROVEL™ Gel is supplied in glass bottles, each containing 25 mL of the gel. The glass bottle, in turn, is put up for retail sale in a paperboard box that also contains a brush applicator, sealed in plastic, in a separate compartment. According to the package insert, all three products are indicated “[F]or debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar.”

The applicable subheading for all three products will be 3004.90.9145, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Dermatological agents and local anesthetics.” The general rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-463-6332.

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 Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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