KERACTIL PLUS- antifungal gel

KERACTIL by

Drug Labeling and Warnings

KERACTIL by is a Otc medication manufactured, distributed, or labeled by POLIMEROS Y SERVICIOS S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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INGREDIENTS AND APPEARANCE

KERACTIL  PLUS
antifungal gel

Product 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)