Label: FOAMING HAND SANITIZER WITH ALOE- 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 November 16, 2010

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE  0.1% 

  • Purpose

    Antimicrobial

  • Uses

    To help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse with water.

    Stop using and ask a doctor

    if irritation or rash develops and lasts

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    Pump enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

  • Inactive Ingredients

    Water, Polysorbate 20, Ethylhexyl Methoxycinnamate, Ethylhexyl Sallicylate, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance, Tetrasodium EDTA, DMDM Hydantoin, Sodium Hydroxide, Blue 1, Yellow 5

  • Package Front and Back Labels

    ht.jpgFront and Back Labels

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER  WITH ALOE
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72036-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1000 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    OCTISALATE (UNII: 4X49Y0596W)  
    PROPYLENE OXIDE (UNII: Y4Y7NYD4BK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72036-240-08236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/16/2010
    Labeler - HARRIS TEETER (047279351)
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