NDC Code(s) : 0067-6239-42, 0067-6239-21
Packager : Novartis Consumer Health, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LAMISIL AT TERBINAFINE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0067-6239
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE(UNII: G7RIW8S0XP)
(TERBINAFINE - UNII:G7RIW8S0XP) 		TERBINAFINE10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBITAN MONOLAURATE(UNII: 6W9PS8B71J)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0067-6239-421 in 1 CONTAINER
112 g in 1 TUBE
2NDC:0067-6239-211 in 1 CONTAINER
26 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021958 01/01/2010

PRINCIPAL DISPLAY PANEL

Lamisil AT Antifungal Gel[Enter image caption here]