Label: ABUTOL ANTISEPTIC WET WIPES LEMON AND MINT- 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 September 1, 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 contact, rinse eyes thoroughly with water 

    Stop use and ask a doctor if

    • irritation and 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

    benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water, 

  • SPL UNCLASSIFIED SECTION

    PARIS
    ANTISEPTIC AGENT

    You may also report any serious side effects to

    PO BOX 328, Wood Ridge, NJ 07075-328

    Distributed By: American Brands and More LLC, Wood Ridge, NJ 07075

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  • Packaging

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  • INGREDIENTS AND APPEARANCE
    ABUTOL ANTISEPTIC WET WIPES  LEMON AND MINT
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78850-101
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78850-101-0120 in 1 PACKET09/01/2020
    12.87 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:78850-101-02120 in 1 PACKET09/01/2020
    23.6 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 finalpart333A09/01/2020
    Labeler - FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI (356117981)
    Establishment
    NameAddressID/FEIBusiness Operations
    FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI356117981manufacture(78850-101)
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