Label: UNICOWIPES- benzethonium 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 April 23, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient                                            Purpose

    Benzethonium Chloride 0.2% ....................... Antibacterial

  • PURPOSE

    Uses: decreases bacteria on skin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Unicowipes

  • WARNINGS

    Warnings:

    For external use only

    Do not use if  you have allergic to any of the ingredients

    When using this product do not get into eyes. If contact occurs, rinse thoroughly with water

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

  • DOSAGE & ADMINISTRATION

    Directions:

    Tear the pack. Pull out the wet wipe. 

    Use wet wipe to clean hands, face or legs without soap or water and discard.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    deionized water, cocoamido propyl betain, glycerin pharma, mono propylene glycol, PEG-7 glycery cocoate, polysorbate-20, fragrance, citric acid, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    UNICOWIPES 
    benzethonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69652-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.001 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69652-000-001 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/19/2015
    Labeler - Sabah Gida Saglik Temizlik Urunleri Dolum Ve Ambalaj Sana (365616970)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sabah Gida Saglik Temizlik Urunleri Dolum Ve Ambalaj Sana365616970manufacture(69652-000)
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