KERACTIL Plus: Package Insert and Label Information

KERACTIL PLUS- tolnaftate gel
POLIMEROS Y SERVICIOS S.A.

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KERACTIL PLUS antifungal gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69492-014 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 10 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE CETOSTEARYL ALCOHOL HYDROGEN PEROXIDE METHYLPARABEN ORTHOSILICIC ACID POLYOXYL 20 CETOSTEARYL ETHER PROPYLPARABEN SODIUM PHOSPHATE, DIBASIC WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69492-014-06 1 TUBE in 1 BOX contains a TUBE 1 10 g in 1 TUBE This package is contained within the BOX (69492-014-06)

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	Operations
POLIMEROS Y SERVICIOS S.A.		815740251	manufacture (69492-014)

Revised: 03/2019 POLIMEROS Y SERVICIOS S.A.

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