Label: HI CLEANER- hypochlorous acid spray

  • 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 October 15, 2020

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

  • ACTIVE INGREDIENT

    Hypochlorous Acid 0.003%

  • INACTIVE INGREDIENTS

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

  • PURPOSE

    Antiseptic

  • WARNINGS

    For external use only-hands.
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    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.

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    Stop use and ask a doctor if skin irritation or rash develops.

  • 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

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

  • Directions

    ■ Shake the bottle.
    ■ Turn the lock cap to the side.
    ■ Spray enough into your hands. Rub until your hands are dry.
    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

  • 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 CLEANER 
    hypochlorous acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71672-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.009 g  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    LEMON OIL (UNII: I9GRO824LL)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    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:71672-040-01300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2020
    Labeler - Eco Face Shop (694860266)
    Registrant - Eco Face Shop (694860266)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eco Face Shop694860266manufacture(71672-040)