Label: SANE WATER- hypochlorous acid liquid

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 21, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient                         Purpose

    Hypochlorous Acid 0.046%            Antimicrobial

  • PURPOSE

  • Uses

    For hand sanitizing to decrease bacteria on skin.

    Recommended for repeated use.

  • Warning

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Use whenever soap and water are not available to supplement regular hand washing.
    • Apply liberally to hands and rub hands together to thoroughly cover hands until product is dry.
  • Inactive Ingredient

    Water

  • Product Labels

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  • INGREDIENTS AND APPEARANCE
    SANE WATER 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73747-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.46 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73747-001-0159.15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/21/2020
    2NDC:73747-001-02473.18 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/21/2020
    3NDC:73747-001-033785.41 mL in 1 JUG; Type 0: Not a Combination Product03/21/2020
    4NDC:73747-001-0418927.1 mL in 1 JUG; Type 0: Not a Combination Product03/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/21/2020
    Labeler - ECOLOGIC SOLUTIONS INC. (796830896)
    Establishment
    NameAddressID/FEIBusiness Operations
    ECOLOGIC SOLUTIONS INC.796830896manufacture(73747-001)