Label: ANUBISMED- ha hyaluronic cream

  • 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 5, 2023

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  • ACTIVE INGREDIENT

    Hyaluronic cream ingredients

  • INACTIVE INGREDIENT

    Hyaluronic cream inactive and active ingredients

  • INDICATIONS & USAGE

    Hyaluronic cream indications

  • DO NOT USE

    Hyaluronic cream do not use

  • KEEP OUT OF REACH OF CHILDREN

    Hyaluronic cream keep out section

  • DOSAGE & ADMINISTRATION

    Hyaluronic cream how to use

  • WARNINGS

    Hyaluronic cream warnings

  • PURPOSE

    Hyaluronic cream purpose

  • PRINCIPAL DISPLAY PANEL

    Hyaluronic cream display panel

  • INGREDIENTS AND APPEARANCE
    ANUBISMED 
    ha hyaluronic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.05 g  in 50 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF2.5 g  in 50 mL
    FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.225 g  in 50 mL
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE0.875 g  in 50 mL
    TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE0.3 g  in 50 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.0535 g  in 50 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1.996 g  in 50 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN) CETYL ALCOHOL0.0038 g  in 50 mL
    TROPOLONE (UNII: 7L6DL16P1T) (TROPOLONE - UNII:7L6DL16P1T) TROPOLONE0.004 g  in 50 mL
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.0004 g  in 50 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.25 g  in 50 mL
    1,2-HEXANEDIOL (UNII: TR046Y3K1G) (1,2-HEXANEDIOL - UNII:TR046Y3K1G) 1,2-HEXANEDIOL0.198 g  in 50 mL
    IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA0.15 g  in 50 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0.25 g  in 50 mL
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE1.75 g  in 50 mL
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES1.5 g  in 50 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) (CAPRYLYL GLYCOL - UNII:00YIU5438U) CAPRYLYL GLYCOL0.198 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.4965 g  in 50 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.4975 g  in 50 mL
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) (GLYCERYL STEARATE SE - UNII:FCZ5MH785I) GLYCERYL STEARATE SE1.5 g  in 50 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER27.4065 mL  in 50 mL
    C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339) (C12-20 ACID PEG-8 ESTER - UNII:9M7A3K4339) C12-20 ACID PEG-8 ESTER2.25 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 50 mL
    DECYL OLEATE (UNII: ZGR06DO97T) (DECYL OLEATE - UNII:ZGR06DO97T) DECYL OLEATE1.9996 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PHOSPHATE (UNII: VT07D6X67O) 0.1463 g  in 50 mL
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) 0.05 g  in 50 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.25 g  in 50 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83021-750-5050 mL in 1 JAR; Type 0: Not a Combination Product10/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/17/202201/16/2028
    Labeler - ANUBIS COSMETICS SL (468680293)
    Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANUBIS COSMETICS SL468680293manufacture(83021-750)