Label: STE-MEDI- hypochlorous acid liquid

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

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Drug Label Information

Updated June 4, 2020

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  • Active Ingredient

    Hypochlorous acid water (HOCL) 90%

    Ethyl Alcohol 5%

    Tea tree oil 0.2%, Chamaecyparis obtusa oil 0.15%, Lavender oil 0.15%

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizer to reduce skin bacteria and viruses on the skin

  • Warnings

    External use only: hand

    When disinfecting the object, spray it and wipe it with a dry cotton cloth.

  • When using this product

    Avoid the eyes. If it gets into your eyes, rinse them thoroughly with water.

    Do not inhale or ingest.

  • Stop use and ask a doctor if

    Irritation or redness develops

  • Keep out of reach of children.

    If swallowed, seek medical attention.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping

    For children under 6, use only adult supervision

    Not recommended for infants

  • Other information

    Do not store above 105F

    May discolor certain fabrics

  • Inactive ingredients

    Hyaluronic acid, chitosan, allantoin, witch hazel extract

  • Package Label

    50ml NDC: 77599-202-01 Label

    100ml NDC: 77599-202-02 Label

    200ml NDC: 77599-202-03 Label

    300ml NDC: 77599-202-04 Label

    500ml NDC: 77599-202-05 Label

  • INGREDIENTS AND APPEARANCE
    STE-MEDI 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77599-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID90 g  in 100 mL
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.2 g  in 100 mL
    CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62) (CHAMAECYPARIS OBTUSA WOOD OIL - UNII:P2OMP71Y62) CHAMAECYPARIS OBTUSA WOOD OIL0.15 g  in 100 mL
    LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8) LAVENDER OIL0.15 g  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONIC ACID (UNII: S270N0TRQY)  
    POLIGLUSAM HYDROCHLORIDE (UNII: F351U03I47)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77599-202-0150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/04/2020
    2NDC:77599-202-02100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/04/2020
    3NDC:77599-202-03200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/04/2020
    4NDC:77599-202-04300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/04/2020
    5NDC:77599-202-05500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/04/2020
    Labeler - ELLAMUSE KOREA (695538826)
    Registrant - ELLAMUSE KOREA (695538826)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELLAMUSE KOREA695538826manufacture(77599-202)
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