Label: DIONA CELL REGENERATION BOOSTER- 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 September 27, 2018

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  • ACTIVE INGREDIENT

    Glycerin

  • INACTIVE INGREDIENT

    WATER, 1,2-HEXANEDIOL, ADENOSINE, BUTYLENE GLYCOL, ETC.

  • PURPOSE

    Skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply an appropriate amount to skin and absorb it.

  • WARNINGS

    1) If following symptoms occur after product use, stop using immediately and consult with a specialist: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DIONA CELL REGENERATION BOOSTER 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72573-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.045 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72573-0001-112 in 1 BOX09/01/2018
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34709/01/2018
    Labeler - VAATZ CO., LTD. (695058942)
    Registrant - VAATZ CO., LTD. (695058942)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESEL Co., Ltd.557836898manufacture(72573-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    VAATZ CO., LTD.695058942label(72573-0001)
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