Label: AEWAJIN DERMA HYDROCELL- glycerin cream

  • Category: HUMAN OTC DRUG LABEL

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 November 23, 2019

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    propylene glycol, niacinamide, allantoin, adenosine, disodium EDTD, etc.

  • PURPOSE

    whitening, wrinkle care

  • 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 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73466-0004
    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:73466-0004-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2019
    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(73466-0004)