Label: ANTIMICROBIAL WIPES CITRUS SCENTED- 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 November 7, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.13% w/w

  • Purpose

    Antimicrobial

  • Uses

    • for hand cleaning to decrease bacteria on the skin
    • kills 99.9% of most common germs
  • Warnings

    For external use only

    When using this product

    • do not use in or near eyes
    • discontinue use if irritation and redness develop

    Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

    • Use textured side of wipe to clean hands
    • wet hands thoroughly with product
    • allow to dry without rinsing
  • Other information

    • store at room temperature
  • Inactive ingredients

    Water, 2-Phenoxyethanol, Alkylpolyglucoside, C 8-10,C10-16, Fragrance, Lauramine,N,N-dimethyl, N-oxide, Tocopherol acetate, Aloe barbadensis leaf juice, PEG-40 Lanolin, Tetrasodium EDTA, Methylchloroisothiazoline, Methylisothiazoline.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    AFFLAB    ™
    AFFILIATED LABORATORIES
    A Division of AFFLINK, 1400 Afflink Place, Tuscaloosa, AL 35406

  • PRINCIPAL DISPLAY PANE - Canister Label

    AFFLAB™
    AFFILIATED LABORATORIES

    ANTIMICROBIAL WIPES

    Citrus Scented

    • Kills 99.9% of common germs
    • Contains Aloe and Vitamin E
    • Moisturizes and conditions skin
    • Alcohol free

    KEEP OUT OF REACH OF CHILDREN
    WARNING
    For external use only.

    Dual Textured
    Wipe

    Contains 70
    12″ x 10″ Pre-Moistened Wipes

    All Hands®
    HAND CARE PRODUCTS

    Principal Display Panel - Canister Label
  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL WIPES CITRUS SCENTED 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54057-681
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.01417 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54057-681-9770 in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E11/05/2012
    Labeler - AFFLABS, Affiliated Laboratories, A Division of AFFLINK (023121150)
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