WL-AAD-Z-W-1189 by Nanophase Technologies Corporation / Nanophase Technologies Cirporation WL-AAD-Z-W-1189

WL-AAD-Z-W-1189 by

Drug Labeling and Warnings

WL-AAD-Z-W-1189 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-AAD-Z-W-1189- 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-AAD-Z-W-1189

WL-AAD-Z-W-1189

WL-AAD-Z-W-1189 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4482
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
TOCOPHEROL (UNII: R0ZB2556P8)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
COCO-CAPRYLATE (UNII: 4828G836N6)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
NYLON-12 (UNII: 446U8J075B)
PHENYLPROPANOL (UNII: 0F897O3O4M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4482-1	160000000 mL in 1 DRUM; Type 0: Not a Combination Product	10/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/22/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Cirporation (623502044)

Revised: 10/2021

Document Id: ceb46cbb-bcb1-7de1-e053-2995a90a2767

34390-5

Set id: ceb4752b-8918-3f98-e053-2a95a90a3151

Version: 1

Effective Time: 20211019