Label: HYDRO H- arbutin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 9, 2014

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  • ACTIVE INGREDIENT

    arbutin

  • INACTIVE INGREDIENT

    water, hyaluronic acid,copper tripeptide-1, tripeptide-29, ginsenosides, etc


  • PURPOSE

    skin whitening
    skin protectant



  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply proper amount to the skin


  • WARNINGS

    ・Stop using the product when you have skin problems or the product disagrees with your skin
    ・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
    ・If the product gets into the eyes, don't rub but rinse with water.
    ・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    HYDRO H 
    arbutin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69422-5001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF) ARBUTIN2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69422-5001-120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/09/2014
    Labeler - General Bio Co., Ltd. (688299527)
    Registrant - General Bio Co., Ltd. (688299527)
    Establishment
    NameAddressID/FEIBusiness Operations
    General Bio Co., Ltd.688299527manufacture(69422-5001)
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