Label: AEWAJIN DERMA HYDROCELL 24K GOLD SERUM- glycerin liquid

  • 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 22, 2020

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    Water
    Butylene Glycol
    Sodium Hyaluronate
    Glycerin
    Propylene Glycol
    Niacinamide
    Trehalose
    Betaine
    Polysorbate 80
    PEG/PPG-17/6 Copolymer
    Disodium EDTA
    GOLD
    Fragrance
    Triethanolamine
    Chlorphenesin
    Phenoxyethanol
    Adenosine
    Chrysanthemum Indicum Callus Culture Extract
    Anthemis Nobilis Flower Extract
    Centella Asiatica Extract
    Allantoin
    Hamamelis Virginiana Extract
    Aloe Barbadensis Leaf Extract
    Rosa Centifolia Flower Extract
    Galactomyces Ferment Filtrate
    Bifida Ferment Extract

  • PURPOSE

    skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    take a suitable amount on the skin

  • WARNINGS

    ■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist

    red specks, swelling, itching

    ■ don’t use on the part where there is injury, eczema, or dermatitis

    Keep out of reach of children

    ■ if swallowed, get medical help or contact a person control center immediately

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AEWAJIN DERMA HYDROCELL 24K GOLD SERUM 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73466-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73466-0005-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34711/16/2019
    Labeler - MISOCOS (695640173)
    Registrant - MISOCOS (695640173)
    Establishment
    NameAddressID/FEIBusiness Operations
    MISOCOS695640173manufacture(73466-0005)
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