SILKA  RINGWORM- clotrimazole cream 
Genomma Lab USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Silka®
Ringworm

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

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

Other information

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)

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)

Principal Display Panel - 14.2 g Tube Carton
SILKA   RINGWORM
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-111-051 in 1 CARTON12/21/2018
114.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/1995
Labeler - Genomma Lab USA, Inc. (832323534)

Revised: 1/2019
Document Id: 1691123d-162c-416f-a8ed-1cb779f9a1c3
Set id: c4e26aa4-248b-48f2-8cdb-630f094259f7
Version: 1
Effective Time: 20190124
 
Genomma Lab USA, Inc.