Label: AKTIVE MULTI PURPOSE ANTIBACTERIAL- hypochlorous acid liquid

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

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Drug Label Information

Updated November 24, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a Antibacterilal Spray manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The Antibacterilal Spray is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Hypochlorous Acid (EPA Reg# 96048-1) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Sterile distilled water or boiled cold water.
    3. Sodium Chloride

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Hypochlorous Acid (EPA Reg# 96048-1)

  • Purpose

    Sanitizing/Antimicrobial Agent Solution is on the EPA N-List N-Product with Emerging Viral Pathogens and Human Coronavirus claims for use against SARS CoV-2

  • Use

    Decreases bacteria on skin.

  • Warnings

    For external use only.

  • Do not use

    If you are allergic to the ingredient. Avoid contact to the eyes and skin. May irritate eyes or sensitive skin. If contact occurs rinse thoroughly with water.

  • 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 develops and continues for more than 72 hrs

  • 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

    Adults and children 2 years and over: Spray on area and allow to dry without wiping. Children should be supervised when using and those under 2 years of age ask doctor before use. Discard empty bottle in trash receptacle.

  • Other information

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

    purified water, Sodium Clhoride

  • Package Label - Principal Display Panel

    package label printable display panel000 mL NDC: 00000-000-00

  • INGREDIENTS AND APPEARANCE
    AKTIVE MULTI PURPOSE ANTIBACTERIAL 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81156-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.25 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.05 mg  in 100 mg
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81156-002-08236 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - Hall Global LLC (117729725)
    Registrant - Hall Global LLC (117729725)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hall Global LLC117729725manufacture(81156-002)
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