Label: BEKLYN ABSOLUTE PURIFYING HAND GEL- titanium dioxide, hypochlorous acid gel

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

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Drug Label Information

Updated July 15, 2020

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  • ACTIVE INGREDIENT

    titanium dioxide, hypochlorous acid

  • INACTIVE INGREDIENT

    Carbomer, Foeniculum Vulgare Fruit Extract, Maltitol, Polygonum Tinctorium Leaf Extract, Sorbitol, Triethanolamine, Water

  • PURPOSE

    Hand sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    • Squeeze enough product in your palm to cover hands and rub hands together until dry.
    • For children under 6 years use adult supervision
    • Not recommended for infants
  • WARNINGS

    For external use only. 

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs develop and persist for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BEKLYN ABSOLUTE PURIFYING HAND GEL 
    titanium dioxide, hypochlorous acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71544-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.03 g  in 300 mL
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.024 g  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    FOENICULUM VULGARE FRUIT (UNII: J5W36Y5WG8)  
    MALTITOL (UNII: D65DG142WK)  
    PERSICARIA TINCTORIA LEAF (UNII: FU6582QMPV)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71544-0004-1300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/15/2020
    Labeler - MY Corp.,Ltd (688202781)
    Registrant - MY Corp.,Ltd (688202781)
    Establishment
    NameAddressID/FEIBusiness Operations
    MY Corp.,Ltd688202781manufacture(71544-0004) , label(71544-0004) , pack(71544-0004)
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