Label: LAMISIL AT- terbinafine hydrochloride aerosol, spray
- NDC Code(s): 0067-6296-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated August 16, 2021
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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
- for athlete’s foot between the toes spray twice a day (morning and night) for 1 week or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- for jock itch and ringworm spray affected area 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
- Inactive ingredients
Principal Display Panel
TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL
Clinically proven to cure most athlete’s foot between the toes
Full prescription strength
Relieves itching, burning, cracking and scaling
Net Contents 125 ml (4.2 fl oz)
The only 1 week (twice a day)athlete’s foot spray
Trademarks are owned by or licensed to the GSK group of companies.
GSK Consumer Healthcare,
Warren, NJ 07059
©2017 GSK or its licensor.
INGREDIENTS AND APPEARANCE
terbinafine hydrochloride aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6296 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:0067-6296-01 125 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)