Label: HAND SANITIZER- hypochlorous acid solution

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

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Drug Label Information

Updated July 31, 2020

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  • Active Ingredient(s)

    Hypochlorous Acid 95% v/v.

  • Purpose

    Purpose: Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • 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 eyes, ears, and mouth. In case of contact with eyes, rinse eyes 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • 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, Sodium Chloride, Seawater, Collodial Gold

  • Package Label - Principal Display Panel

    50mL NDC:79841 -001-05

    50 mL Spray

    100 mL NDC:79841 -001-10

    100 mL Spray

    450 mL NDC:79841 -001-45

    450 mL Spray

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hypochlorous acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79841-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID95 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GOLD (UNII: 79Y1949PYO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MERCURY (UNII: FXS1BY2PGL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79841-001-0550 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
    2NDC:79841-001-10100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
    3NDC:79841-001-45450 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/31/2020
    Labeler - THAI WACOAL PUBLIC COMPANY LIMITED (659934301)
    Establishment
    NameAddressID/FEIBusiness Operations
    IREAL PLUS (THAILAND) COMPANY LIMITED671902247manufacture(79841-001)
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