WL-AAB-Z-W-1819 by Nanophase Technologies Corporation WL-AAB-Z-W-1819

WL-AAB-Z-W-1819 by

Drug Labeling and Warnings

WL-AAB-Z-W-1819 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-1819- 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-1819

WL-AAB-Z-W-1819

GHS

WL-AAB-Z-W-1819 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63931-1819
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE132 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
ISODODECANE (UNII: A8289P68Y2)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63931-1819-1150000 mL in 1 DRUM; Type 0: Not a Combination Product06/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/02/2023
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-1819)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-1819) , manufacture(63931-1819)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(63931-1819) , pack(63931-1819)

Revised: 7/2023