Label: ANTIBACTERIAL WET WIPES- triclosan swab

  • 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 March 12, 2012

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  • Active Ingredient

    Triclosan(0.2%)

    Purpose

    Antibacterial
  • Use

    decreases bacteria on skin
  • WARNINGS

    For External use only.
    Do not use 
       .over large areas of the body
       .if your are allergic to any of the ingredients
    When using this product
       Do not get into eyes,if contact occurs ,rinse throughly with water.
    Stop use and ask a doctor,if irritation or rash develops and continues for than 72 hours

    keep out of reach of children

    if swallowed ,get medical help or contact o poison Control Center right away
  • Directions

    Adults and children 2 years and over:use on hands and face to clean and refresh allow skin to air dry.
    Children under 2 years ,ask a doctor before use
  • Inactive ingredients

    WATER,Tocopherol,Propylene Glycol,Aloe,Sodium Chlorite,Benzoic Acid,Lanolin, METHYLCHLOROISOTHIAZOLINONE , METHYLISOTHIAZOLINONE
  • PRINCIPAL DISPLAY PANEL

    label

    section text here

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    triclosan swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42856-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Tocopherol (UNII: R0ZB2556P8)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Aloe (UNII: V5VD430YW9)  
    Sodium Chlorite (UNII: G538EBV4VF)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Lanolin (UNII: 7EV65EAW6H)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42856-001-0140 in 1 PACKAGE
    12.25 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/12/2012
    Labeler - MAKESELLER GROUP INC. (421285330)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAKESELLER GROUP INC. 421285330manufacture
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