Label: WL-AAB-Z-W-1173- zinc oxide lotion
- NDC Code(s): 63931-4480-1
- Packager: Nanophase Technologies Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 2, 2021
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- WL-AAB-Z-W-1173
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INGREDIENTS AND APPEARANCE
WL-AAB-Z-W-1173
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4480 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 ALLANTOIN (UNII: 344S277G0Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) 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) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4480-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 08/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/26/2021 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-4480) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(63931-4480) , manufacture(63931-4480) , pack(63931-4480) Establishment Name Address ID/FEI Business Operations Amcol Health & Beauty Solutions 872684803 api manufacture(63931-4480)