Label: PHYSICAL 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 May 12, 2021

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  • SPL UNCLASSIFIED SECTION

    PHYSICAL WATER

  • Active Ingredient(s)

    HYPOCHLOROUS ACID 0.01mL/50mL. Purpose: Antiseptic

  • Purpose

    Antiseptic, PHYSICAL WATER

  • Use

    PHYSICAL WATER to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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.

  • Directions

    • Spray on the skin.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    WATER
    POTASSIUM IODATE

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    PHYSICAL WATER  
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81910-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID10 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM IODATE (UNII: I139E44NHL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81910-101-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/12/2021
    2NDC:81910-101-02350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/12/2021
    Labeler - Fengzhuo Energy conservation and Environmental protection Technology (551036927)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fengzhuo Energy conservation and Environmental protection Technology551036927manufacture(81910-101)
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