Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Nanophase Technologies Corporation
TOPICAL
OTC DRUG
OTC monograph not final
WL-AAB-Z-W-1350- 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._ ---------- WL-AAB-Z-W-1350 WL-AAB-Z-W-1350 WL-AAB-Z-W-1350 zinc oxide lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:63931-4516 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 FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TOCOPHEROL (UNII: R0ZB2556P8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) GLYCERIN (UNII: PDC6A3C0OX) 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- 4516-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 02/23/2022 Nanophase Technologies Corporation MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING S Read the complete document