WL-AAB-Z-W-1803 by Nanophase Technologies Corporation WL-AAB-Z-W-1803

WL-AAB-Z-W-1803 by

Drug Labeling and Warnings

WL-AAB-Z-W-1803 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAB-Z-W-1803- 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-AAB-Z-W-1803

WL-AAB-Z-W-1803 GHS Label

WL-AAB-Z-W-1803 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-1803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	107 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALLANTOIN (UNII: 344S277G0Z)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISODODECANE (UNII: A8289P68Y2)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-1803-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	03/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/20/2023

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-1803)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-1803) , manufacture(63931-1803)

Revised: 7/2023

Document Id: 00d72196-d25f-94de-e063-6394a90ac02b

34390-5

Set id: 00d720f7-f323-918a-e063-6394a90a0dd8

Version: 1

Effective Time: 20230719