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NDC 00067-6297-01 LAMISIL 0.84 g/125mL Details

LAMISIL 0.84 g/125mL

LAMISIL is a TOPICAL AEROSOL, SPRAY 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	00067-6297
Product ID	0067-6297_1d96797c-7a93-40e9-8332-4aa2ccdcd129
Associated GPIs
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
Non-Proprietary Name	TERBINAFINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	0.84
Active Ingredient Units	g/125mL
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	NDA021124
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00067-6297-01 (00067629701)

Pricing Information	N/A
NDC Package Code	0067-6297-01
Billing NDC	00067629701
Package	125 mL in 1 CAN (0067-6297-01)
Marketing Start Date	2018-03-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a262ea43-d9c5-4574-8ba9-2bb3c09e8160 Details

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

•: cures most jock itch (tinea cruris)
•: relieves itching, burning, cracking, and scaling which accompany this condition

Warnings

For external use only

Do not use

•: on nails or scalp
•: in or near the mouth or the eyes
•: for vaginal yeast infections

When using this product

•: do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
•: do not puncture or incinerate; contents under pressure. Do not expose to heat or store at temperatures above 120ºF (49ºC).

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:

•: wash the affected area with soap and water and dry completely before applying
•: to open remove clear cap
•: hold can 4" to 6" from skin. Press and hold to spray a thin layer over affected area
•: spray affected area once a day (morning or night) for 1 week or as directed by a doctor
•: release to stop spray
•: wipe excess from spray opening after each use
•: return cap to can
•: wash hands after each use

•

children under 12 years: ask a doctor

Other information

store at 20° to 25° C (68° to 77° F)

Inactive ingredients

ethanol, polyoxyl 20 cetostearyl ether, propylene glycol, purified water

Questions?

call 1-800-330-9876

Principal Display Panel

NDC 0067-6297-01

TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL

LAMISILAT®

SPRAY for JOCK ITCH

Cures most jock itch

For effective relief of itching and burning

Net Contents 125 ml (4.2 fl oz)

1-800-330-9876

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

13058

INGREDIENTS AND APPEARANCE

LAMISIL AT

terbinafine hydrochloride aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-6297
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE HYDROCHLORIDE	0.84 g in 125 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-6297-01	125 mL in 1 CAN; Type 0: Not a Combination Product	03/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021124	03/07/2018

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

Revised: 8/2021

Document Id: 1d96797c-7a93-40e9-8332-4aa2ccdcd129

Set id: a262ea43-d9c5-4574-8ba9-2bb3c09e8160

Version: 4

Effective Time: 20210816