Label: SPATHERAPY- 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 April 7, 2014

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  • INACTIVE INGREDIENT

    Inactive Ingredients - Water, Sodium Laureth

    Sulfate, Cocamidopropyl Betaine, Glycerin, DMDM

    Hydantoin, Benalkonium Clhoride, Fragrance,

    Xanthan Gum, Disodium EDTA,

    Citiric Acid. May contain: CI 14700, CI 17200, CI 19140, Ci 42090

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride  0,2 %

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Use - handwashing to decrease bacteria on skin

  • DOSAGE & ADMINISTRATION

    Directions - wet hands, work into

    rich lather - rinse well

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product, avoid contact with eyes. If contact occurs,

    rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop

  • KEEP OUT OF REACH OF CHILDREN

    EKeep out of reach of children. If swallowed, get medical help

    or contact a Poison Control Center right away.

  • QUESTIONS

    Questions? 1-800-FDA-1088

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SPATHERAPY  
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.56 g  in 293 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-011-01293 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/27/2014
    Labeler - Xiamen Olivee Daily Use Chemical Co., Ltd. (526021375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Olivee Daily Use Chemical Co., Ltd.526021375manufacture(56136-011)
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