Label: ANTIBACTERIAL HAND SANITIZER LAVENDER SCENT- benzalkonium chloride lotion

  • 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 August 28, 2020

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  • ACTIVE INGREDIENT

    Active ingredient               BENZALKONIUM CHLORIDE ........... 0.1 w/w

  • PURPOSE

    Antibacterial

  • USE

    To decrease bacteria on the skin that could cause disease.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center right away.

  • WARNINGS

    For external use only

    When using this product 

    • Keep out of eyes. In case of contact flush eyes with water, and seek medical advise.

    Stop use and ask a doctor 

    • If irritation or redness develops.
    • condition persists for more than 72 hours.
  • DOSAGE & ADMINISTRATION

    Apply a small amount to palm and rub hands together thoroughly.

  • INACTIVE INGREDIENT

    Water, Glycerin, Stearic Acid, Mineral Oil, Cetaryl Alcohol, Ethylhexyl Palmltate, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Triethanolamine, DMDM Hydantoin, Fragrance, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER LAVENDER SCENT 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74149-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74149-035-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/28/2020
    Labeler - Yiwu Yangjie Daily Chemicals Co.,Ltd. (529648827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Yangjie Daily Chemicals Co.,Ltd.529648827manufacture(74149-035)