SILKA RINGWORM- clotrimazole cream

Silka by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• cures most ringworm
• relieves itching, redness, irritation and discomfort which accompany this condition

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

Do not use on children under 2 years of age unless directed by a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• use daily for 4 weeks
• if condition persists longer, ask a doctor
• this product is not effective on the scalp or nails

Other information

• To open: unscrew cap, use the pointed end of cap to puncture seal.
• store between 20°- 25°C (68° - 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

Call 1 877 99 GENOM (43666)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

SILKA®
Clotrimazole Cream USP, 1%
ANTIFUNGAL CREAM

CURES MOST RINGWORM

NET WT 0.5 oz (14.2 g)

INGREDIENTS AND APPEARANCE

SILKA   RINGWORM
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)	Clotrimazole	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
benzyl alcohol (UNII: LKG8494WBH)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetyl esters wax (UNII: D072FFP9GU)
octyldodecanol (UNII: 461N1O614Y)
polysorbate 60 (UNII: CAL22UVI4M)
sorbitan monostearate (UNII: NVZ4I0H58X)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-111-05	1 in 1 CARTON	12/21/2018
1		14.2 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
OTC monograph final	part333C	06/01/1995

Labeler - Genomma Lab USA, Inc. (832323534)