Label: MELAN RX- zinc oxide lotion
- NDC Code(s): 82635-403-01
- Packager: Melan RX
- 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 March 7, 2023
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- Melan RX
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INGREDIENTS AND APPEARANCE
MELAN RX
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82635-403 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALLANTOIN (UNII: 344S277G0Z) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM CHLORIDE (UNII: 451W47IQ8X) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) FERRIC OXIDE RED (UNII: 1K09F3G675) 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) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-TOCOPHEROL (UNII: 9U6A490501) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8) Product Characteristics Color pink Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82635-403-01 45 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/23/2022 Labeler - Melan RX (038285055) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(82635-403) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(82635-403) , manufacture(82635-403) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(82635-403) , pack(82635-403)