Label: PURELOGIC EUCALYPTUS ANTIBACTERIAL HAND- benzalkonium chloride soap

  • 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 1, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose: 

    Antibacterial

  • Use

    Helps eliminate bacteria on hands

  • Warnings

    For external use only

  • When using this product

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

  • Stop use and ask a doctor

    if redness and irrigation develop and last

  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    Apply onto wet hands. Lather and rinse thoroughly

  • Other information

    Store at room temperature

  • Inactive ingredients

    Water, Sodium lauroamphoacetate, Cocamidopropylamine oxide, Cocamidopropyl betaine, Glycerin, Olea europaea (olive) leaf extract, Polyminopropyl biguanide, Citric acid, Disodium EDTA, Benzophenone-3, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Cetylpyridinium chloride,  Blue 1 (CI42090)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PURELOGIC EUCALYPTUS ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77731-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77731-057-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Labeler - Argento sc by sicura inc. (168718778)
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