Label: HAND SANITIZER- 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 December 30, 2022

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  • Active Ingredient                                                        Purpose

    Benzalkonium Chloride (0.1 %)--------------------- Antimicrobial

  • PURPOSE

  • Uses

    For hand sanitizing to decrease bacteria on the skin.

  • Warnings

    For external uses only. / When using this products avoid contact of eyes. In case of eye contact, flush eyes with water. / Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours. /Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply a small amount into palm of hands and rub hands together briskly until dry.

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive Ingredients

    water, glycerin, stearic acid, cetostearyl alcohol, mineral oil, propylene glycol, trietanolamine, benzophenone-3, polysorbate 60, PEG 12-
    dimethicone, glyceryl stearate, fragance, imidazolidinyl urea, propyl paraben, carbomer, tocopheryl acetate, tetrasodium EDTA, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1 , FD&C Red No. 40.

  • Principal display panel

    label

    carton

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73360-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    IMIDUREA (UNII: M629807ATL)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73360-001-014 in 1 CARTON09/20/2019
    128 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:73360-001-0228 mL in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/20/2019
    Labeler - Harmonia de Venezuela CA (817307290)
    Establishment
    NameAddressID/FEIBusiness Operations
    Harmonia de Venezuela CA817307290manufacture(73360-001)
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