NDC Code(s) : 67405-450-66
Packager : Harris Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CiclopiroxCiclopirox SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67405-450
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
Ethyl Acetate(UNII: 76845O8NMZ)
Isopropyl Alcohol(UNII: ND2M416302)
Maleic Acid(UNII: 91XW058U2C)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67405-450-666.6 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078233 09/19/2007

PRINCIPAL DISPLAY PANEL

Harris
Pharmaceutical

NDC 67405-450-66

Ciclopirox
Topical
Solution 8%
(Nail Lacquer)

FOR DERMATOLOGIC
USE ONLY
NOT FOR USE IN EYES

Rx Only

One
6.6 mL Bottle

Ciclopirox Topical Solution, 8%
(Nail Lacquer)

Each gram of Ciclopirox Topical Solution, 8%, (Nail Lacquer), contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol.

Usual Dosage:  Apply to the affected nails once daily.  See package insert for full prescibing information.

WARNING:  Keep out of reach of children.

Important:  This package is not child resistant.

Store at room temperature between 59-86°F (15-30°C).  Protect bottle from light.

CAUTION:  Flammable.  Keep away from heat and flame.

Store bottle in carton after every use.