SILKA  ANTIFUNGAL- terbinafine hydrochloride cream 
Genomma Lab USA, Inc.

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Silka® Antifungal

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

Other information

Inactive ingredients

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

Questions?

1 877 994 3666 Monday to Friday, 8 am to 6 pm Central time.

Distributed by:
Genomma Lab USA Inc., Houston, TX, 77027

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Terbinafine Hydrochloride Cream 1% - Antifungal

SILKA®

ANTIFUNGAL CREAM FOR ATHLETE'S FOOT

Full prescription strength

NET WT.
1 oz (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
SILKA   ANTIFUNGAL
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-080
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:50066-080-021 in 1 CARTON07/02/2007
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:50066-080-031 in 1 CARTON05/21/2018
230 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:50066-080-051 in 1 CARTON12/20/2018
315 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 - Genomma Lab USA, Inc. (832323534)
Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(50066-080)

Revised: 9/2020
Document Id: 643e3ebb-9ae5-4c8a-985d-94807195e055
Set id: a32cf699-e63e-4bd3-a5af-9e1ba447e02e
Version: 4
Effective Time: 20200915
 
Genomma Lab USA, Inc.