Label: SMILE ANTIBACTERIAL WET WIPES PLANTAIN EXTRACT- benzalkonium chloride cloth

  • 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 9, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0,1%

    Purpose

    Antibacterial

  • Uses

    kill germs and remove dirt

  • Warnings

    For external use only

    Don't use 

    if you are alleric to any of the any of ingredients

    When using this product

    do not get into eyes. If contact occurs, wash thoroughly with water

    Stop use and ask doctor

    if irritation or rash develops and continuous for more than 72 hours

    Keep out of reach of children

  • Directions

    • Adults and children 3 years and over
    • Children under 3 years ask a doctor before use
    • Wipe with wipes and let dry
  • Inactive ingredients:

    aqua, glycerin, propylene glycol, plangato major leaf extract, PEG-40 hydrogenated castro oil, cocamidopropyl betaine, PPG-2-methyl ether, ethylparaben, 2-bromo-2-nitropropane-1,3-doil, centrimonium bromide, citric acid, parfum, linalool, butylphenyl methylpropional

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    SMILE ANTIBACTERIAL WET WIPES PLANTAIN EXTRACT 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81119-001
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81119-001-1515 in 1 PACKAGE05/01/2020
    12.28 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - KPD, Limited Liability Company (681241494)
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