WL-AAJ-Z-W-870 by Nanophase Technologies Corporation / Nanophase Technologies Cirporation WL-AAJ-Z-W-870

WL-AAJ-Z-W-870 by

Drug Labeling and Warnings

WL-AAJ-Z-W-870 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation, Nanophase Technologies Cirporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAJ-Z-W-870- zinc oxide lotion 
Nanophase Technologies Corporation

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.

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WL-AAJ-Z-W-870

WL-AAJ-Z-W-870

WL-AAJ-Z-W-870 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SQUALANE (UNII: GW89575KF9)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYESTER-7 (UNII: 0841698D2F)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
ISODECYL SALICYLATE (UNII: S7097PFP4C)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
ISOSTEARIC ACID (UNII: X33R8U0062)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4420-1	160000000 mL in 1 DRUM; Type 0: Not a Combination Product	03/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Cirporation (623502044)

Revised: 3/2021

Document Id: bd982f11-9fff-56b7-e053-2995a90a6997

34390-5

Set id: bd982d33-8428-00f6-e053-2995a90a255c

Version: 1

Effective Time: 20210315