Skip to Content

Silka Antifungal

Medically reviewed on June 8, 2018

Dosage form: cream
Ingredients: Terbinafine Hydrochloride 1g in 100g
Labeler: Genomma Lab USA, Inc.
NDC Code: 50066-080

Silka®
Antifungal

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses
  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions

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.

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.

Other information
  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 20°-25°C (68°-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?

1 877 99 GENOM (43666) 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

Cures Most Athlete's Foot

SILKA®

Terbinafine Hydrochloride Cream 1%
Antifungal Cream
NET WT. 1 oz (30 g)

SILKA   ANTIFUNGAL
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-080
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (Terbinafine) Terbinafine1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetyl alcohol 
cetyl palmitate 
isopropyl myristate 
polysorbate 60 
water 
sodium hydroxide 
sorbitan monostearate 
stearyl alcohol 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50066-080-021 TUBE in 1 CARTON
130 g in 1 TUBE
2NDC:50066-080-031 TUBE in 1 CARTON
230 g in 1 TUBE
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/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(50066-080)

 
Genomma Lab USA, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide