Label: HI HAND CLEAN- 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 September 7, 2020

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  • ACTIVE INGREDIENT

    Hypochlorous Acid 0.003%

  • INACTIVE INGREDIENTS

    Allantoin, Aloe Barbadensis Leaf powder, Butylene Glycol, Carbomer, Citrus Limon(Lemon) Peel Oil/ Limonene, Citral, Glycerin, L-Arginine, Melaleuca Alternifolia(Tea Tree)Leaf Extract, Menthol, Niacinamide, Water, 1,2-Hexanediol

  • PURPOSE

    Antiseptic and skin protection

  • WARNINGS

    For external use only.
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    Do not use

    • in childre  n less than 2 months of age
    • on open skin wounds
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    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

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

  • Uses

    • instant hand antiseptic to decrease bacteria on the skin

  • Directions

    • Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
    • Supervise children in the use of this product.

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • Avoid UV rays
    • Notice by fair trade commission in case of any abnormality in this product we •Manufacturing date and period of use : three years from date of manufacture

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    HI HAND CLEAN 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71672-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.015 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Glycerin (UNII: PDC6A3C0OX)  
    Menthol (UNII: L7T10EIP3A)  
    Niacinamide (UNII: 25X51I8RD4)  
    Water (UNII: 059QF0KO0R)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71672-030-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2020
    Labeler - Eco Face Shop (694860266)
    Registrant - Eco Face Shop (694860266)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eco Face Shop694860266manufacture(71672-030)