Terbinafine Hydrochloride

Terbinafine Hydrochloride by

Drug Labeling and Warnings

Terbinafine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream 
Sun Pharmaceutical Industries, Inc.

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Terbinafine Hydrochloride

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • relieves itching, burning, cracking and scaling which accompany this condition

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 productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor iftoo 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
    • apply once a day (morning ornight) for 1 weekor as directed by a doctor
    • wash hands after each use
  • children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.

  • store at controlled room temperature 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

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

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

Cures Most Jock Itch

Full Prescription Strength

Terbinafine Hydrochloride
Cream 1%
Antifungal

NET WT 0.42 oz (12 g)

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
TERBINAFINE HYDROCHLORIDE 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51672-2083
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: 51672-2083-81 in 1 CARTON07/02/200702/12/2026
112 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/200702/12/2026
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295manufacture(51672-2083)

Revised: 2/2026
Document Id: 4aa7c49b-3d41-8914-e063-6394a90a250f
Set id: 3639d7f5-fee5-489c-9916-9a235d283830
Version: 2
Effective Time: 20260212