Label: ELECTROLYZED WATER- hypochlorous acid spray

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

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Drug Label Information

Updated February 1, 2022

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  • Active Ingredient

    Hypochlorous Acid 0.05%

  • Purpose

    Antiseptic

  • Uses

    • to prevent and treat infection of the skin
  • Warnings

    For external use only

  • Stop use and ask a doctor if

    • redness, irritation or swelling or pain persists or increases.
  • Do not use

    • if sensitive to chlorine compounds.
    • Do not mix with other chemicals.
    • if swallowed, get medical help or contact a Poison Control Center right away.
  • Keep out of reach of children

    Keep out of reach of children

  • Directions

    • to use as liquid sterilization by immersing completely for about 3 to 5 minutes.
    • For instruments that are difficult to immerse, spray and sterilize for about 3 minutes before wiping off.
  • Questions and Comments

    Use this product only below 65°C

    Do not immerse for more than 30 minutes to prevent corrosion and damage to equipment made of ferrous metal

  • Inactive Ingredient

    Water

  • PRINCIPAL DISPLAY PANEL

    3785 mL NDC:80932-002-37

    3785 mL3785 mL Back Panel

  • INGREDIENTS AND APPEARANCE
    ELECTROLYZED WATER 
    hypochlorous acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80932-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80932-002-373785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/13/2021
    Labeler - ROOTS BEAUTY INNOVATIONS LLC (111051318)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROOTS BEAUTY INNOVATIONS LLC111051318manufacture(80932-002)
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