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 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

image 1

1 week between the toes

       • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor

image 2

2 weeks on the bottom or sides of the foot

    • 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

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

Trademarks owned or licensed by GSK. 2019 GSK or licensor.

Principal display panel

NDC 0067-3998-30

LAMISIL AT Cream

gsk

TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

FOR ATHHLETE’S FOOT

NET WT 30 g (1 oz)

13508 Front

13508 Lamisil AT 30g (1 oz)
LAMISIL  AT
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-3998
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE10 mg  in 1 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-3998-421 in 1 CARTON08/10/200511/30/2025
112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0067-3998-301 in 1 CARTON08/10/200511/30/2025
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02098008/10/200511/30/2025
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: e5b8a1ab-1fbf-4e14-8244-1695977c6c7b
Set id: de5def4a-f77f-4ea6-a497-24f041c1f123
Version: 8
Effective Time: 20240325
 
Haleon US Holdings LLC