Label: LAMISIL AT- terbinafine hydrochloride aerosol, spray
- NDC Code(s): 0067-6297-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 7, 2018
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- Active ingredient
For external use only
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).
- 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
- Inactive ingredients
Principal Display Panel
TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL
SPRAY for JOCK ITCH
Cures most jock itch
For effective relief of itching and burning
Net Contents 125 ml (4.2 fl oz)
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.
INGREDIENTS AND APPEARANCE
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)