TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream 
Taro Pharmaceuticals U.S.A., Inc.

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Terbinafine Hydrochloride
Cream 1%
Antifungal Cream

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.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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
Figure 1
2 weeks on the bottom or sides of the foot
Figure 2

Other information

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - 30 g Carton

Cures Most Athlete's Foot
Terbinafine Hydrochloride
Cream 1%
Antifungal Cream

Full Prescription Strength

NET WT 1 oz (30 g)

Principal Display Panel - 30 g Carton
TERBINAFINE HYDROCHLORIDE 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2080
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:51672-2080-11 in 1 CARTON07/02/2007
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2080-21 in 1 CARTON07/02/2007
230 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:51672-2080-81 in 1 CARTON07/02/2007
312 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:51672-2080-91 in 1 CARTON07/02/2007
424 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:51672-2080-61 in 1 CARTON07/02/2007
545 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:51672-2080-31 in 1 CARTON07/02/2007
660 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:51672-2080-41 in 1 CARTON04/24/2017
715 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/2007
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2080)

Revised: 5/2017
Document Id: 8440d9a3-c2bd-462e-98b2-74faa0818949
Set id: 92b31fc4-0f02-4857-b11f-49b9f942ee84
Version: 2
Effective Time: 20170505
 
Taro Pharmaceuticals U.S.A., Inc.