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 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?

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)

Revised: 1/2019
Document Id: 39848469-9f54-4303-a5ea-2c711368b88c
Set id: 326d8586-042f-44f8-8530-e46b7b777bc3
Version: 1
Effective Time: 20190111
 
Genomma Lab USA, Inc.