Label: BEKLYN ABSOLUTE PURIFYING-SPRAY- titanium dioxide, 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 July 15, 2020

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  • ACTIVE INGREDIENT

    titanium dioxide, hypochlorous acid

  • INACTIVE INGREDIENT

    Foeniculum Vulgare Fruit Extract, Maltitol, Polygonum Tinctorium Leaf Extract, Sorbitol, 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

    • Spray directly, from a distance of about 8 to 10 inches 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-SPRAY 
    titanium dioxide, hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71544-0002
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71544-0002-1300 mL in 1 BOTTLE, SPRAY; 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(71544-0002) , label(71544-0002) , pack(71544-0002)