LAMISIL AT- terbinafine hydrochloride cream 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis)
cures most jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do not use

on nails or scalp
in or near the mouth or eyes
for vaginal yeast infections

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if too much irritation occurs or gets worse

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over:
use the tip of the cap to break the seal and open the tube
wash the affected skin with soap and water and dry completely before applying
for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
wash hands after each use
children under 12 years: ask a doctor
Figure

Other information

do not use if seal on tube is broken or is not visible
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

Questions or comments?

call 1-800-330-9876

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

PRINCIPAL DISPLAY PANEL

NDC 0067-8100-30

TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL
gsk

LAMISILAT ® CREAM

Relieves Itching, Burning, Cracking and Scaling
NET WT 30 g (1 oz)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
LAMISIL AT 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8100-121 in 1 CARTON07/02/2007
112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0067-8100-301 in 1 CARTON07/02/2007
230 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0067-8100-151 in 1 CARTON04/24/2017
315 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/2007
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2020
Document Id: 3831085f-f03b-4da1-823c-9574561dd92f
Set id: a9f8dfc5-8891-43bd-8fd9-9c61d78f2e64
Version: 6
Effective Time: 20201208
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC