WL-AAB-Z-W-404: Package Insert and Label Information

WL-AAB-Z-W-404- zinc oxide lotion
Nanophase Technologies Corporation

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WL-AAB-Z-W-404

GHS Label
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 132 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LAURYL PEG-8 DIMETHICONE (300 CPS)
FERRIC OXIDE YELLOW
ALKYL (C12-15) BENZOATE
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 500
ALLANTOIN
SODIUM HYDROXIDE
WATER
NIACINAMIDE
ETHYLHEXYLGLYCERIN
HEXYLENE GLYCOL
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)
PROPANEDIOL
TETRASODIUM GLUTAMATE DIACETATE
SODIUM CHLORIDE
PHENOXYETHANOL
TOCOPHEROL
DIMETHICONE
TRILAURETH-4 PHOSPHATE
BUTYLOCTYL SALICYLATE
OCTYLDODECYL NEOPENTANOATE
ISODODECANE
.ALPHA.-BISABOLOL, (+)-
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
FERRIC OXIDE RED
Product Characteristics
Color brown Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63931-4532-1 150000 mL in 1 DRUM None
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 Operations
Nanophase Technologies Corporation 050383046 api manufacture (63931-4532)
Establishment
Name Address ID/FEI Operations
Nanophase Technologies Corporation 623502044 api manufacture (63931-4532), manufacture (63931-4532), pack (63931-4532)

Revised: 08/2022 Nanophase Technologies Corporation

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