WL-AAD-Z-W-987 by Nanophase Technologies Corporation WL-AAD-Z-W-987

WL-AAD-Z-W-987 by

Drug Labeling and Warnings

WL-AAD-Z-W-987 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAD-Z-W-987- 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-987

WL-AAD-Z-W-987

WL-AAD-Z-W-987 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE (UNII: 4828G836N6)
NYLON-12 (UNII: 446U8J075B)
PHENYLPROPANOL (UNII: 0F897O3O4M)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALLANTOIN (UNII: 344S277G0Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4432-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	05/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/04/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-4432)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-4432) , manufacture(63931-4432) , pack(63931-4432)

Revised: 4/2022

Document Id: dcedb866-43b4-05bc-e053-2a95a90ab09f

34390-5

Set id: cc1104a8-1d07-dbc6-e053-2a95a90a2e02

Version: 2

Effective Time: 20220418