LAMISIL AT- terbinafine hydrochloride cream 
Haleon US Holdings 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 CARTON07/02/200702/28/2022
112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0067-8100-301 in 1 CARTON07/02/200707/31/2022
230 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0067-8100-151 in 1 CARTON04/24/201711/30/2019
315 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/200707/31/2022
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
 
Haleon US Holdings LLC