Label: MEDIAQUA PREMIUM- hypochlorous acid liquid

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

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Drug Label Information

Updated September 2, 2020

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  • ACTIVE INGREDIENT

    Hypochlorous Acid

  • INACTIVE INGREDIENT

    WATER, sodium chloride

  • PURPOSE

    sterilization, disinfection

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Apply an appropriate amount on your hands and rub well to dry.

  • WARNINGS

    1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and ears, in the oral cavity (may have irritating effects)
    2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
    1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
    2) Skin irritation symptoms

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MEDIAQUA PREMIUM 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80458-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80458-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/03/2020
    Labeler - Mediecotech co ltd (694790898)
    Registrant - Mediecotech co ltd (694790898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mediecotech co ltd694790898manufacture(80458-0001)
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