Lamisil by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Drug Facts

Lamisil by

Drug Labeling and Warnings

Lamisil by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

LAMISIL  AT
terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-3998
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE HYDROCHLORIDE	10 mg  in 1 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-3998-42	1 in 1 CARTON	08/10/2005	11/30/2025
1		12 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0067-3998-30	1 in 1 CARTON	08/10/2005	11/30/2025
2		30 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
NDA	NDA020980	08/10/2005	11/30/2025

Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024

Document Id: e5b8a1ab-1fbf-4e14-8244-1695977c6c7b

34390-5

Set id: de5def4a-f77f-4ea6-a497-24f041c1f123

Version: 8

Effective Time: 20240325