KAISER PERMANENTE TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream 
Kaiser Foundation Hospitals

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KAISER PERMANENTE ®

Terbinafine Hydrochloride

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 the eyes
  • for vaginal yeast infections

When using this product do not get into the 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 older
    • 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
1 week between the toes
Image
2 weeks on the bottom
or sides of the foot
Image

Other information

Inactive ingredients

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

Questions?

Call 1-866-923-4914

Manufactured by
Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Distributed by
Kaiser Foundation Hospitals
Livermore, CA 94551-9756

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

KAISER PERMANENTE ®

Terbinafine Hydrochloride Cream 1%
ANTIFUNGAL CREAM
CURES MOST ATHLETE'S FOOT

Compare to the active ingredient in Lamisil AT ®*

NET WT 1 OZ (30 g)

Principal Display Panel - 30 g Tube Carton
KAISER PERMANENTE  TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8715
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE1 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:0179-8715-301 in 1 CARTON07/02/200706/30/2020
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/200706/30/2020
Labeler - Kaiser Foundation Hospitals (053052619)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295manufacture(0179-8715)

Revised: 11/2018
Document Id: 7b0aea92-ee73-8b64-e053-2991aa0aa6f1
Set id: 2a342421-fc4b-4c21-a394-5ddb9d4a96d5
Version: 2
Effective Time: 20181119
 
Kaiser Foundation Hospitals