Label: ANUBIS BARCELONA REGUL OIL- peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract concentrate

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 1, 2023

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  • DOSAGE & ADMINISTRATION

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  • INACTIVE INGREDIENT

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  • INGREDIENTS AND APPEARANCE
    ANUBIS BARCELONA REGUL OIL 
    peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-624
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.512 mL  in 10 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL0.04 g  in 10 mL
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED0.0345 g  in 10 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.0138 g  in 10 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT0.00007 g  in 10 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.025 g  in 10 mL
    POWDERED CELLULOSE (UNII: SMD1X3XO9M) (POWDERED CELLULOSE - UNII:SMD1X3XO9M) POWDERED CELLULOSE0.0006 g  in 10 mL
    PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN0.0000002 g  in 10 mL
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.000002 g  in 10 mL
    FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.02 g  in 10 mL
    ETHYLPARABEN (UNII: 14255EXE39) (ETHYLPARABEN - UNII:14255EXE39) ETHYLPARABEN0.0000003 g  in 10 mL
    ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE0.0001 g  in 10 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER6.2503117 mL  in 10 mL
    TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE0.02 g  in 10 mL
    LEVOMENOL (UNII: 24WE03BX2T) (LEVOMENOL - UNII:24WE03BX2T) LEVOMENOL0.009 g  in 10 mL
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) (HYDROXYETHYL CELLULOSE, UNSPECIFIED - UNII:T4V6TWG28D) HYDROXYETHYL CELLULOSE, UNSPECIFIED0.034 g  in 10 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.0012 g  in 10 mL
    FARNESOL (UNII: EB41QIU6JL) (FARNESOL - UNII:EB41QIU6JL) FARNESOL0.001 g  in 10 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN0.0100013 g  in 10 mL
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.005 g  in 10 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.000006 g  in 10 mL
    BUTYLPARABEN (UNII: 3QPI1U3FV8) (BUTYLPARABEN - UNII:3QPI1U3FV8) BUTYLPARABEN0.0000005 g  in 10 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.0002 g  in 10 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.000006 g  in 10 mL
    CITRAL (UNII: T7EU0O9VPP) (CITRAL - UNII:T7EU0O9VPP) CITRAL0.000194 g  in 10 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.00419 g  in 10 mL
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) (FD&C YELLOW NO. 5 - UNII:I753WB2F1M) FD&C YELLOW NO. 50.00002 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) 0.0006 g  in 10 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.005 g  in 10 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.0001 g  in 10 mL
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.000098 g  in 10 mL
    SODIUM ACETATE (UNII: 4550K0SC9B) 0.003 g  in 10 mL
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.01 g  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83021-624-1010 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00610/21/202207/07/2027
    Labeler - ANUBIS COSMETICS SL (468680293)
    Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANUBIS COSMETICS SL468680293manufacture(83021-624)