Label: KERACTIL PLUS- antifungal gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69492-014-06 - Packager: POLIMEROS Y SERVICIOS S.A.
- 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 March 5, 2019
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INGREDIENTS AND APPEARANCE
KERACTIL PLUS
antifungal gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69492-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) HYDROGEN PEROXIDE (UNII: BBX060AN9V) METHYLPARABEN (UNII: A2I8C7HI9T) ORTHOSILICIC ACID (UNII: 623B93YABH) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69492-014-06 1 in 1 BOX 03/04/2019 1 10 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 03/09/2016 Labeler - POLIMEROS Y SERVICIOS S.A. (815740251) Establishment Name Address ID/FEI Business Operations POLIMEROS Y SERVICIOS S.A. 815740251 manufacture(69492-014)
