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NDC 00067-3999-42 Lamisil 10 mg/g Details

Lamisil 10 mg/g

Lamisil is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is TERBINAFINE HYDROCHLORIDE.

Product Information

NDC	00067-3999
Product ID	0067-3999_331b6cb8-35ae-483d-be2e-350d6c565175
Associated GPIs	90150087103710
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Lamisil
Proprietary Name Suffix	AT Jock Itch
Non-Proprietary Name	TERBINAFINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	TERBINAFINE HYDROCHLORIDE
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	Allylamine Antifungal [EPC], Allylamine [CS]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA020980
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00067-3999-42 (00067399942)

Pricing Information	N/A
NDC Package Code	0067-3999-42
Billing NDC	00067399942
Package	1 TUBE in 1 CARTON (0067-3999-42) / 12 g in 1 TUBE
Marketing Start Date	2006-12-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1757a9c4-e989-4f2d-bedc-0ba5137c68dc Details

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

•: 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
•: 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.

13510 (Front Carton)

Principal Display Panel

NDC 0067-3999-42

LAMISIL AT CREAM

gsk

TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

FOR JOCK ITCH

NET WT 12 g (0.42 oz)

13510 (Front Carton)

INGREDIENTS AND APPEARANCE

LAMISIL AT JOCK ITCH

terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-3999
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0067-3999-42	1 in 1 CARTON	12/08/2006
1		12 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020980	12/08/2006

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 6/2021

Document Id: 331b6cb8-35ae-483d-be2e-350d6c565175

Set id: 1757a9c4-e989-4f2d-bedc-0ba5137c68dc

Version: 3

Effective Time: 20210615