Label: ANUBIS BARCELONA- peg-40 hydrogenated castor oil, propylene glycol, allantoin concentrate

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 1, 2023

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  • ACTIVE INGREDIENT

    RO Concentrate ingredients

  • INDICATIONS & USAGE

    RO Concentrate indications

  • DO NOT USE

    RO Concentrate do not use

  • KEEP OUT OF REACH OF CHILDREN

    RO Concentrate keep

  • DOSAGE & ADMINISTRATION

    RO Concentrate dosage

  • WARNINGS

    RO Concentrate warnings

  • INACTIVE INGREDIENT

    RO Concentrate ingredients list

  • PURPOSE

    RO Concentrate purpose

  • PRINCIPAL DISPLAY PANEL

    RO Concentrate display

  • INGREDIENTS AND APPEARANCE
    ANUBIS BARCELONA 
    peg-40 hydrogenated castor oil, propylene glycol, allantoin concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-617
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN0.0000001 g  in 5 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0125 g  in 5 mL
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.0025 g  in 5 mL
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) (FD&C YELLOW NO. 5 - UNII:I753WB2F1M) FD&C YELLOW NO. 50.00001 g  in 5 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.0069 g  in 5 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT0.000035 g  in 5 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN0.00500065 g  in 5 mL
    TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE0.01 g  in 5 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER3.12515585 mL  in 5 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1.756 mL  in 5 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL0.02 g  in 5 mL
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED0.01725 g  in 5 mL
    ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE0.00005 g  in 5 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.000003 g  in 5 mL
    ETHYLPARABEN (UNII: 14255EXE39) (ETHYLPARABEN - UNII:14255EXE39) ETHYLPARABEN0.00000015 g  in 5 mL
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.000001 g  in 5 mL
    CITRAL (UNII: T7EU0O9VPP) (CITRAL - UNII:T7EU0O9VPP) CITRAL0.000097 g  in 5 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.002095 g  in 5 mL
    POWDERED CELLULOSE (UNII: SMD1X3XO9M) (POWDERED CELLULOSE - UNII:SMD1X3XO9M) POWDERED CELLULOSE0.0003 g  in 5 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.0006 g  in 5 mL
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) (HYDROXYETHYL CELLULOSE, UNSPECIFIED - UNII:T4V6TWG28D) HYDROXYETHYL CELLULOSE, UNSPECIFIED0.017 g  in 5 mL
    LEVOMENOL (UNII: 24WE03BX2T) (LEVOMENOL - UNII:24WE03BX2T) LEVOMENOL0.0045 g  in 5 mL
    FARNESOL (UNII: EB41QIU6JL) (FARNESOL - UNII:EB41QIU6JL) FARNESOL0.0005 g  in 5 mL
    FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.01 g  in 5 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.000003 g  in 5 mL
    BUTYLPARABEN (UNII: 3QPI1U3FV8) (BUTYLPARABEN - UNII:3QPI1U3FV8) BUTYLPARABEN0.00000025 g  in 5 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.0001 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) 0.0003 g  in 5 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.00005 g  in 5 mL
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.000049 g  in 5 mL
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.005 g  in 5 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.0025 g  in 5 mL
    SODIUM ACETATE (UNII: 4550K0SC9B) 0.0015 g  in 5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83021-617-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product10/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00610/21/202209/20/2027
    Labeler - ANUBIS COSMETICS SL (468680293)
    Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANUBIS COSMETICS SL468680293manufacture(83021-617)
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