KERACTIL PLUS (ANTIFUNGAL) GEL [POLIMEROS Y SERVICIOS S.A.]

KERACTIL PLUS (ANTIFUNGAL) GEL [POLIMEROS Y SERVICIOS S.A.]
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NDC	69492-014-06
Set ID	0605381a-83cf-401d-86cf-a6a41b15355e
Category	HUMAN OTC DRUG LABEL
Packager	POLIMEROS Y SERVICIOS S.A.
Generic Name
Product Class
Product Number
Application Number	PART333C

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General view of box content of labeling

Caja con cambios Keractil Plus.jpg

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Detail showing Active Ingredient from package

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	03/09/2016

Labeler - POLIMEROS Y SERVICIOS S.A. (815740251)

Name	Address	ID/FEI	Business Operations
Establishment
POLIMEROS Y SERVICIOS S.A.		815740251	manufacture(69492-014)

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