LAMISIL by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Drug Facts

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]

LAMISIL AT CONTINUOUS- terbinafine hydrochloride liquid 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

• cures most athlete’s foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of foot is unknown.
• 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 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 120 ºF (49 ºC).

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
    • 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

store at 20 - 25°C (68 - 77°F)

Inactive ingredients

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

Questions?

call 1-800-452-0051

Principal Display Panel

NDC: 0067-6292-83

TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL

LAMISILAT®Spray

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

LAMISIL  AT CONTINUOUS
terbinafine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-6292
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: 0067-6292-83	125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/23/2009	09/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021124	07/23/2009	09/30/2019

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

Revised: 8/2019

Document Id: c22d7b4c-8bfd-4433-ac94-90bd1b96ac69

34390-5

Set id: 8a8f2d12-a621-4334-b790-7879704aeff8

Version: 3

Effective Time: 20190809

 

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC