Label: DIAMOND WIPES ANTIBACTERIAL HAND 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 February 25, 2020

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  • Active ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Directions

    • For hand washing to decrease bacteria on skin
    • reccomended for repeated use
  • Warnings

    For external use only

    When using this product

    avoid contact with eyes

    Stop use and ask a doctor 

       If irritation or redness 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 packet
    • remove and unfold wipes
    • wipe hands thoroughly for approximately 15 seconds
    • do not flush
  • Inactive ingredients

    Alcohol Denat., Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Polysorbate 20, Sorbic Acid, Tocopheryl Acetate, Water

  • PRINCIPAL DISPLAY PANEL

    • Diamond Wipes
    • Antibacterial Hand Wipes
    • Kills 99% of Germs
    • Aloe vera and Vitamin E
    • Made in USA

    label

  • INGREDIENTS AND APPEARANCE
    DIAMOND WIPES ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64709-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Sorbic acid (UNII: X045WJ989B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    water (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64709-101-101.8 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2010
    Labeler - Diamond Wipes International, Inc. (161104729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes International, Inc.161104729manufacture(64709-101)
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