WL-AAB-Z-W-404- zinc oxide lotion

WL-AAB-Z-W-404 by

Drug Labeling and Warnings

WL-AAB-Z-W-404 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-404

INGREDIENTS AND APPEARANCE

WL-AAB-Z-W-404 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4532
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
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4532-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	08/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/02/2022

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-4532)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-4532) , manufacture(63931-4532) , pack(63931-4532)