Label: LUCKY ALCOHOL FREE HAND SANITIZER VITAMIN E- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 21, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    hand sanitizer to help reduce bacteria on the skin that could cause disease

  • Warnings

    For external use only

  • When using this product

    do not get into the eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if


    if irritation or rash appears and lasts

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ place enough product in your palm ■ rub hands vigorously until dry ■ children under 6 years of age should be supervised when using this product

  • Other information

    ■ store below 106ºF (41ºC) ■ may discolor certain fabrics or surfaces

  • Inactive ingredients

    water, glycerin, carbomer, poly sorbate 20, PEG-40 hydrogenated castor oil, fragrance, sodium hydroxide, methylchloroisothiazolinone, methylisothiazolinone, tocopheryl acetate

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    LUCKY ALCOHOL FREE HAND SANITIZER  VITAMIN E
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-139-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2020
    2NDC:20276-139-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/10/2020
    Labeler - Delta Brands, Inc (102672008)