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

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Lamisil AT®

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

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
Figure

Other information

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)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
LAMISIL AT 
terbinafine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8100
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol (UNII: LKG8494WBH)  
cetyl alcohol (UNII: 936JST6JCN)  
cetyl palmitate (UNII: 5ZA2S6B08X)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
polysorbate 60 (UNII: CAL22UVI4M)  
water (UNII: 059QF0KO0R)  
sodium hydroxide (UNII: 55X04QC32I)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0067-8100-12 1 in 1 CARTON 07/02/2007
1 12 g in 1 TUBE; Type 0: Not a Combination Product
2 NDC:0067-8100-30 1 in 1 CARTON 07/02/2007
2 30 g in 1 TUBE; Type 0: Not a Combination Product
3 NDC:0067-8100-15 1 in 1 CARTON 04/24/2017
3 15 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077511 07/02/2007
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 5/2017
Document Id: ce681c5e-448a-44b1-895d-7f80228fb92f
Set id: a9f8dfc5-8891-43bd-8fd9-9c61d78f2e64
Version: 5
Effective Time: 20170505
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC