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NDC 00067-8100-12 Lamisil AT 1 g/100g Details

Lamisil AT 1 g/100g

Lamisil AT 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	00067-8100
Product ID	0067-8100_3831085f-f03b-4da1-823c-9574561dd92f
Associated GPIs	90150087103710
GCN Sequence Number	018273
GCN Sequence Number Description	terbinafine HCl CREAM (G) 1 % TOPICAL
HIC3	Q5F
HIC3 Description	TOPICAL ANTIFUNGALS
GCN	62498
HICL Sequence Number	007590
HICL Sequence Number Description	TERBINAFINE HCL
Brand/Generic	Brand
Proprietary Name	Lamisil AT
Proprietary Name Suffix	n/a
Non-Proprietary Name	Terbinafine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
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	ANDA
Application Number	ANDA077511
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00067-8100-12 (00067810012)

Pricing Information	N/A
NDC Package Code	0067-8100-12
Billing NDC	00067810012
Package	1 TUBE in 1 CARTON (0067-8100-12) / 12 g in 1 TUBE
Marketing Start Date	2007-07-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a9f8dfc5-8891-43bd-8fd9-9c61d78f2e64 Details

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LAMISIL AT

terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-8100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)	Terbinafine Hydrochloride	1 g in 100 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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0067-8100-12	1 in 1 CARTON	07/02/2007
1		12 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0067-8100-30	1 in 1 CARTON	07/02/2007
2		30 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:0067-8100-15	1 in 1 CARTON	04/24/2017
3		15 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
ANDA	ANDA077511	07/02/2007

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