Label: CARUCHE PREMIUM HYPOCHLOROUS ACID WATER- hypochlorous acid liquid

  • NDC Code(s): 74841-001-01, 74841-001-02, 74841-001-03
  • Packager: NAP Industrial (Shenzhen) Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 26, 2020

If you are a consumer or patient please visit this version.

  • 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)