Label: PERSONAL WASH CLOTHS- 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 23, 2014

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  • Active ingredient

    Benzalkonium Chloride 0.12%

  • Purpose

    Antibacterial

    (Helps reduce germs)

  • 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.

  • Uses

    Helps kill germs that can potentially cause infection. 
    Helps eliminate odor. 

    Reduces cross contamination

  • Warnings

    For external use only

    Avoid direct contact with eyes.
    Do not use on deep or punctured wounds, serious burns, animal bites

    If irritation or redness develops, and persists for more than 72 hours, stop use and seek medical help.

  • Directions

    Washcloths can be used at room temperature or heated in a microwave for extra comfort. 

    Use one wash cloth for each of the following areas

    1. Face, Neck, Chest 2. Left and right arm, 3. Perineum, 4.Left and Right leg, 5.Back and Buttocks

    Heating instructions

    Place full packet in microwave, peel open label approx. 1 inch and heat for 15 seconds, then, follow bathing instructions.(test temperature to avoid burning skin) gloved hands may reduce sensitivity to heat. Check temperature for infants or skin sensitive individuals

    Do not overheat! Do not reheat.

  • Other informations

    Protect from freezing

    Wash cloth: Spun lace fabric

  • INACTIVE INGREDIENTS

    Deionized water,Propylene Glycol, Glycerin,DMDM Hydantoin, Disodium cocoampho Diacetate, Cocoamide Propyl Betaine, Phenoxyethanol, Dimethicon copolyol(DC-193), DC-245, Polysorbate 20, Peg -40 -Hydrogenated Castor Oil, EDTA Disodium, Vitamin E, Citric Acid/TEA, Fragrance

  • packaging

    LEADING AGE

  • INGREDIENTS AND APPEARANCE
    PERSONAL WASH CLOTHS 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69089-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0155 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69089-101-1010 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/14/2014
    Labeler - Ginni Filaments Limited (650793412)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ginni Filaments Limited650793412manufacture(69089-101)
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