LAMISIL AT- terbinafine hydrochloride cream 
REMEDYREPACK INC.

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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

DRUG: Lamisil AT

GENERIC: Terbinafine Hydrochloride

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-1736-0

COLOR: white

PACKAGING: 30 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

LAMISIL AT 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1736(NDC:0067-8100)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1736-01 in 1 CARTON12/15/2018
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751112/15/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2019
Document Id: 96323da0-ae71-bb1c-e053-2995a90a218a
Set id: 8d2a3b91-2872-40d0-a962-ebf90cf17986
Version: 3
Effective Time: 20191031
 
REMEDYREPACK INC.