POLYACTIL N- skin protectant gel

Polyactil N by

Drug Labeling and Warnings

Polyactil N 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

POLYACTIL N 
skin protectant gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69492-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ORTHOSILICIC ACID (UNII: 623B93YABH)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
XYLITOL (UNII: VCQ006KQ1E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69492-015-05	1 in 1 BOX	06/20/2016
1		30 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	part347	06/20/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
POLIMEROS Y SERVICIOS S.A.		815740251	manufacture(69492-015)