NDC Code(s) : 54868-6064-0
Packager : Physicians Total Care, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ciclopirox Ciclopirox SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6064(NDC:0093-6179)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLOPIROX(UNII: 19W019ZDRJ)
(CICLOPIROX - UNII:19W019ZDRJ) 		CICLOPIROX80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)(UNII: 389H2R62BD)
ETHYL ACETATE(UNII: 76845O8NMZ)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54868-6064-06.6 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078079 09/04/2009

LABELER - Physicians Total Care, Inc.(194123980)

Establishment
Name Address ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel

PRINCIPAL DISPLAY PANEL

Ciclopirox topical solution, 8% (nail lacquer)

image of package label