Label: DISINFECTANT liquid

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

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Drug Label Information

Updated November 16, 2020

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  • USE(S)

    Spray on the surface of the skin or the surface of the object for sterilization & disinfection and to remove odor.

  • WARNINGS

    For external use only. Flammable.Keep away from heat or flame.

  • DO NOT USE

    in children less than 2 months of age

    on open skin wounds

  • WHEN USING

    When using this product keep out of eves, ears, and mouth. ln case of contact with eyes, rinseeyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children lf swallowed, get medical help or contact Poison Control Center right away.

  • PURPOSE

    Disinfection
    Sterilization

  • ACTIVE INGREDIENT

    HCLO(Hypochlorou acid)0.5%

  • Other information

    Store between 15-30°C(59-86°F）
    Avoid freezing and excessive heat above 40°C(104°F)

  • INACTIVE INGREDIENT

    Water

  • DIRECTIONS

    Avoid contact with eyes and mouth.
    lf allergy occurs, discontinue use and consult with your doctor.
    lf a child ingests by accident, get medical advice immediately.
    Please keep it in a cool and dry place.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT 
    disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:94973-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:94973-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/17/2020
    Labeler - Bifone (pinghu) Medical Equipment Co., Ltd (554550799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bifone (pinghu) Medical Equipment Co., Ltd554550799manufacture(94973-001)
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