Label: SILKA RINGWORM- clotrimazole cream
- NDC Code(s): 50066-111-05
- Packager: Genomma Lab USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 24, 2019
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- PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
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INGREDIENTS AND APPEARANCE
SILKA RINGWORM
clotrimazole creamProduct 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)