NDC Code(s) : 11673-080-02
Packager : Target Corporation

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Athletes FootTerbinafine Hydrochloride CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-080
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE HYDROCHLORIDE(UNII: 012C11ZU6G)
(TERBINAFINE - UNII:G7RIW8S0XP) 		TERBINAFINE HYDROCHLORIDE1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
CETYL ALCOHOL(UNII: 936JST6JCN)
CETYL PALMITATE(UNII: 5ZA2S6B08X)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
POLYSORBATE 60(UNII: CAL22UVI4M)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11673-080-021 in 1 CARTON 25/03/2015
130 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077511 07/02/2007

LABELER - Target Corporation(006961700)

Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 manufacture(11673-080)

PRINCIPAL DISPLAY PANEL

up & up

full prescription strength
athlete's foot cream
terbinafine hydrochloride 1% – antifungal

helps cure most athlete's foot, jock itch and ringworm
helps relieve itching, burning, cracking and scaling

NET WT 1 OZ (30 g)

terbinafine-02