Label: DEX ANTIBACTERIAL WIPES- 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 July 4, 2020

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  • Active Ingredient

    Benzalkonium Chloride .13% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Antibacterial Wet Hand Wipes

  • Use

    Antibacterial wet wipes helps reduce bacteria (organisms).Effective on bacterias :Staphylococcus aureus ATCC 6538,Pseudomonas aeruginosa ATCC 15442,Enterococcus hirae ATCC 10541,Escherichia coli ATCC 10536. Use only on hands and away from eyes.

  • Warnings

    Keep away from children and direct sunlight. Children should not use this product without an adult supervision. For external use only. In case of poisoning, call the National Toxitation Information Center. Avoid contact with eyes. This product consists of nonwoven fabric (solid) impregnated with a flammable liquid solution that has an estimated flashpoint of approximately 120 degrees fahrenheit; keep away from heat, sparks, open flames, and hot surfaces. Do not smoke near this product or while using. Keep container tightly closed when not in use.

  • Do Not Use

    Do not use if allergic to any of its ingredients. Do not use near eyes. Consult a doctor before use if pregnant, breastfeeding, have sensitive skin, or are under the age of 12. Do not buy opened and/or damaged products.

  • When Using

    In case of inhaling: If you feel uncomfortable get some fresh air. In case of skin Irritation: Occurs stop using the wipes immediately and wash the affected area with water and soap for at least 15 minutes. People with sensitive skin, pregnant women, breastfeeding women and children under the age of 12 should consult a doctor/pharmacist before using the product. Seek for medical advice if necessary. In case of contact with eyes: If you are wearing contact lenses, remove them immediately. Rince your eyes with plenty of clean water. In case of swallowing: Call your local Toxication Center and get medical help.

  • Stop Using

    Stop use if rednedd or irritation occurs and persists for longer than 48 hours and contact a healthcare professional.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. Children should not use this product without adult supervision.

  • Directions

    Provides practical cleaning without need of water and soap. Used for hand cleaning. Open the adhesive label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required.

  • Other Information

    Do not ingest the product internally. Store in a cool, dry place. Store away from oxidizing agents and food.

  • Inactive Ingredients

    Aqua, Parfum, C12-15 Pareth-12, Glycerin, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA, Piroctone Olamine, Tocopheryl Acetate, Panthenol, Citric Acid

  • Package Label - Principal Display Panel

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    DEX ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78141-800
    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
    C12-15 PARETH-12 (UNII: 131316X18L)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78141-800-02100 g in 1 POUCH; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2020
    Labeler - Fuson LLC (113376279)
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