Label: PEAR ANTI-BACTERIAL FOAMING HAND WASH- benzethonium 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 July 24, 2014

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.


  • When using this product

    Avoid contact with eyes. If contact occurs flush eyes with water.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.


  • Keep out of the reach of children

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

  • Directions

    Wet hands. Apply palmful to hands and forearms. Scrub thoroughly. Rinse and repeat. Dry thoroughly.

  • Inactive Ingredients

    Water (Aqua), Sodium Lauroamphoacetate, Cocomidopropylamine Oxide, Cocamidopropyl Betaine, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Olea Europaea (Olive) Leaf Extract, Fragrance (Parfume), Polyaminopropyl Biguanide, Thymus Vulgaris (Thyme) Oil, Citric Acid, Methylchloroisothiazolinone $ Methylisothiazolinone, Disodium EDTA, Benzophenone-3. May contain: FD&C Red NO. 40 (CI 16035), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090).

  • HOW SUPPLIED

  • PRINCIPAL DISPLAY PANEL

    image of 2796439

  • INGREDIENTS AND APPEARANCE
    PEAR ANTI-BACTERIAL FOAMING HAND WASH 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43333-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 13 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containFD&C RED NO. 40 (UNII: WZB9127XOA)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43333-442-10296 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/24/2014
    Labeler - Tonic Bath and Body Products Shenzhen Ltd. (528197042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tonic Bath and Body Products Shenzhen Ltd.528197042manufacture(43333-442)
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