Label: ABUTOL ANTISEPTIC WET WIPES ENGLISH LAVENDER SCENT- 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 August 27, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    • hand wipes to decrease bacteria on the skin.
    • recommended for repeated use.
    • for use when soap and water are not available
  • Warnings

    For external use only

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product • do not get into eyes. In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • irritation or redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • open resealable label. Pull out wipes. Close resealable label to prevent drying out wipe hands thoroughly with product and allow to dry
    • dispose the wipe after use
    • supervise children under 6 years of age when using this product to avoid swallowing
    • do not flush
  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    Aqua, Glycerin, Propylene glycol, Parfum, Polysorbate-20, Cocamidopropyl Betaine, Corn Oil, Lauryl Glucoside, Polyglyceryl-2 DipolyhydroxyStearate, Glyceryl Oleate, Dicaprylyl Carbonate, Tetrasodium EDTA, Phenoxyethanol, Benzoic Acid, Dehydroacetic acid.

  • SPL UNCLASSIFIED SECTION

    PARIS

    ENGLISH LAVENDER SCENT

    SANITIZING WIPES

    You may also report any serious side effects to
    PO Box 328, Wood Ridge, NJ 07075-328 

    ANTISEPTIC AGENT

    • Sanitizing formula to help reduce cross-contamination and risk of infection.
    • Leaves no stickiness or residue on hands.
    • Hands feel smooth, soft and refreshed.

    To Open Package

    • Flip open dispensing lid
    • Locate wipe at center of roll and thread through small opening in lid
    • For best results dispense wipes at an angle
    • Always close lid securely between uses to retain moisture

    Made in TURKEY

    TO DISPOSE WIPE: Place in a waste basket after use.
    DO NOT FLUSH

    Lot Number and Exp Date on package

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ABUTOL ANTISEPTIC WET WIPES ENGLISH LAVENDER SCENT 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78089-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CORN OIL (UNII: 8470G57WFM)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78089-032-0172 in 1 PACKET08/29/2020
    14.11 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2020
    Labeler - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi (565678914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi565678914manufacture(78089-032)
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