Label: AQUNOVA. WATER INNOVATION- hypochlorous acid liquid

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

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Drug Label Information

Updated September 11, 2020

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  • ACTIVE INGREDIENTS

    Hypochlorous Acid 0.1%

  • PURPOSE

    Antiseptic

  • USES

    Multi purpose sterilization, disinfection

  • WARNINGS

    For external use only

    When using this product

    - Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    - Avoid contact with broken skin.

    - Do not inhale or ingest.

  • WARNINGS

    - Stop immediately and consult a doctor it you experience skin imitation or rash develops.

  • WARNINGS

    - Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    - Spray the sterilizing object in a wide range

    - Please supervise when using the product by children, the elderly, the disabled, etc.

  • OTHER INFORMATION

    - Read the directions and warmings before use

    - If exposed to the air, sterilization may be reduced due to water-soluble, so keep the container sealed.

    - Avoid freezing and excessive heat above 40 degreee C (104 degree F) 40C(104F)

  • INACTIVE INGREDIENTS

    Water

  • PACKAGE LABEL

    40ml NDC: 80542-201-01 Label

    60ml NDC: 80542-201-02 Label

    160ml NDC: 80542-201-03 Label

    300ml NDC: 80542-201-04 Label

    500ml NDC: 80542-201-05 Label

    1000ml NDC: 80542-201-06 Label

    3000ml NDC: 80542-201-07 Label

    5000ml NDC: 80542-201-08 Label

    10000ml NDC: 80542-201-09 Label

    20000ml NDC: 80542-201-10 Label

  • INGREDIENTS AND APPEARANCE
    AQUNOVA. WATER INNOVATION 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80542-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80542-201-0140 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/12/2020
    2NDC:80542-201-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/12/2020
    3NDC:80542-201-03160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/12/2020
    4NDC:80542-201-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2020
    5NDC:80542-201-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2020
    6NDC:80542-201-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2020
    7NDC:80542-201-073000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2020
    8NDC:80542-201-085000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2020
    9NDC:80542-201-0910000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2020
    10NDC:80542-201-1020000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/12/2020
    Labeler - Agricultural Company Corporation, Inc (695005948)
    Registrant - Agricultural Company Corporation, Inc (695005948)
    Establishment
    NameAddressID/FEIBusiness Operations
    Agricultural Company Corporation, Inc695005948manufacture(80542-201)
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