Label: H BIOTICS- 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 November 11, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Hypochlorous ACID

  • PURPOSE

    ANTIMICROBIAL

  • Inactive

    WATER

  • Stop use

    if irritationor rash occurs. These may be signs of a serious contion.

  • ask a doctor.

    if irritationor rash occurs. These may be signs of a serious contion.

  • Warnings

    Please do not use for any other purpose

    keep put of eyes.

    rinse cautiously with water of several minutes.

  • uses

    Hand sanitizer to decrease bacteria on the skin that could cause disease

  • When using this product

    kills over 99% of most common germs.

  • Keep out of reach of children.

    Keep out of reach of children.

  • Other information

    Store between 33.8~86'F
    Avoid freezing and excessive heat

  • directions

    spray on surfaces that require disinfection, sterilation and dedorization.

    dry naturally.

    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.

  • LABEL

    embio279045-301-01

    79045-301-02 150ML

  • INGREDIENTS AND APPEARANCE
    H BIOTICS 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79045-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 99.9 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79045-301-01150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/22/2020
    2NDC:79045-301-0220 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/22/2020
    Labeler - EMBIOME Co., Ltd. (695729257)
    Registrant - EMBIOME Co., Ltd. (695729257)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMBIOME Co., Ltd.695729257manufacture(79045-301)