LAMISIL AT- terbinafine hydrochloride aerosol, spray

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]

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

©2017 GSK or its licensor.

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

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

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

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

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

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