Label: BEKLYN ABSOLUTE PURIFYING HAND GEL REFRESHING ALOE 180ML- titanium dioxide, hypochlorous acid gel

  • 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 4, 2020

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  • ACTIVE INGREDIENT

    titanium dioxide, hypochlorous acid

  • INACTIVE INGREDIENT

    Aloe Vera Extract, Carbomer, Foeniculum Vulgare Fruit Extract, Maltitol, PEG-60, 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 REFRESHING ALOE 180ML 
    titanium dioxide, hypochlorous acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71544-0018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.018 g  in 180 mL
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.0144 g  in 180 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    MALTITOL (UNII: D65DG142WK)  
    POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746)  
    PERSICARIA TINCTORIA LEAF (UNII: FU6582QMPV)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71544-0018-1180 mL in 1 TUBE; Type 0: Not a Combination Product09/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/02/2020
    Labeler - MY Corp.,Ltd (688202781)
    Registrant - MY Corp.,Ltd (688202781)
    Establishment
    NameAddressID/FEIBusiness Operations
    MY Corp.,Ltd688202781manufacture(71544-0018) , label(71544-0018) , pack(71544-0018)