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Lamisil AT by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Dosage form: cream
Ingredients: Terbinafine Hydrochloride 1g in 100g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0067-8100

Lamisil AT®

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses
  • cures most athlete's foot (tinea pedis)
  • 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 eyes
  • for vaginal yeast infections

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

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:
    • use the tip of the cap to break the seal and open the tube
    • wash the affected skin with soap and water and dry completely before applying
    • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
      • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
      • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
    • for jock itch and ringworm: apply 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
  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

Questions or comments?

call 1-800-330-9876

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC 0067-8100-30

TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL
gsk

LAMISILAT ® CREAM

Relieves Itching, Burning, Cracking and Scaling
NET WT 30 g (1 oz)

LAMISIL AT 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (Terbinafine) Terbinafine Hydrochloride1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetyl alcohol 
cetyl palmitate 
isopropyl myristate 
polysorbate 60 
water 
sodium hydroxide 
sorbitan monostearate 
stearyl alcohol 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-8100-121 TUBE in 1 CARTON
112 g in 1 TUBE
2NDC:0067-8100-301 TUBE in 1 CARTON
230 g in 1 TUBE
3NDC:0067-8100-151 TUBE in 1 CARTON
315 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/2007
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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