Label: CARUCHE PREMIUM HYPOCHLOROUS ACID WATER- hypochlorous acid liquid

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

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Drug Label Information

Updated April 26, 2020

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  • SPL UNCLASSIFIED SECTION

    HYPOCHLOROUS ACID 0,4mg/ml

    Water

  • ACTIVE INGREDIENT

    HYPOCHLOROUS ACID 0.4mg/ml

  • PURPOSE

    Products used to kill bacteria and viruses, prevent disease, and suppress spread

  • INDICATIONS & USAGE

    Sterilize by spraying on objects or skin surface

  • WARNINGS

    For external use only.

  • DO NOT USE

    in children less than 2 months of age
    on open skin wounds

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Spray on the surface of objects or human skin

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    water

  • PRINCIPAL DISPLAY PANEL

    100ml NDC: 74841-001-01

    300ml NDC: 74841-001-02

    1000ml NDC: 74841-001-03

    1003001000

  • INGREDIENTS AND APPEARANCE
    CARUCHE PREMIUM HYPOCHLOROUS ACID WATER 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74841-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74841-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    2NDC:74841-001-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    3NDC:74841-001-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/08/2020
    Labeler - NAP Industrial (Shenzhen) Limited (550189474)
    Establishment
    NameAddressID/FEIBusiness Operations
    NAP Industrial (Shenzhen) Limited550189474manufacture(74841-001)
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