SILKA  JOCK ITCH- terbinafine hydrochloride cream 
Genomma Lab USA, Inc.

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Silka ®
Jock Itch

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 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

Other information

Inactive ingredients

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

Questions?

call 1 877 99 GENOM (43666)

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

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

SILKA ®
Terbinafine Hydrochloride Cream 1%
ANTIFUNGAL CREAM

FULL PRESCRIPTION
STRENGTH

JOCK ITCH

CURES MOST JOCK ITCH
NET WT 0.5 oz (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
SILKA   JOCK ITCH
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-208
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:50066-208-051 in 1 CARTON12/20/2018
115 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)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharma Canada Inc. 243339023manufacture(50066-208)

Revised: 7/2025
Document Id: 38f65202-ed21-e74d-e063-6294a90a2882
Set id: 326d8586-042f-44f8-8530-e46b7b777bc3
Version: 2
Effective Time: 20250702
 
Genomma Lab USA, Inc.