SILKA ANTIFUNGAL- terbinafine hydrochloride cream

Silka by

Drug Labeling and Warnings

Silka by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Inc., Taro Pharmaceuticals U.S. A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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° to 25°C (68° to 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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

FULL PRESCRIPTION
STRENGTH

SILKA®
Terbinafine Hydrochloride Cream 1%

ANTIFUNGAL CREAM

CURES MOST ATHLETE'S FOOT

NET WT. 1oz (30 g)

INGREDIENTS AND APPEARANCE

SILKA   ANTIFUNGAL
terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)	Terbinafine	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-080-02	1 in 1 CARTON	07/02/2007
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 50066-080-03	1 in 1 CARTON	05/21/2018
2		30 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 50066-080-05	1 in 1 CARTON	12/20/2018
3		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077511	07/02/2007

Labeler - Genomma Lab USA, Inc. (832323534)

Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(50066-080)