Label: GOODSENSE ANTIBACTERIAL MOISTURIZING- benzalkonium chloride film

  • 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 21, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                                                                Purpose

    Benzalkonium Chloride 0.115% ..........................................Antibacterial

  • PURPOSE

    Uses

    Decreases Bacteria on skin

  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.

    If contact occurs, rinse thoroughly with water.

  • STOP USE

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

  • 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

    Directions

    • Pull top off lid by lifting upward.   Pull sheet from center of roll.  Insert corner of center sheet through flap opening on lid. Replace lid and pull sheet out at a 45 degree angle. The next sheet pops up automatically.  When finished, reseal by closing lid flap to retain moisture.   Do not push finger through dispenser hole.
    • Apply thoroughly to hands and face as desired and allow to dry without wiping.
    • Dispose of wipe in the proper container.
    • Do not flush down the toilet
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Alcohol, Propylene Glycol, Aloe Barbadensis Leaf Extract, Quatemium 52, PEG 60 Lanolin, Potassium Sorbate, Imidazolidinyl Urea Methyl Paraben, Propyl Paraben, Methylchloroisothiazolinone and Methylisothiazolinone, Disodium EDTA, Citric Acid, Fragrance

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Geiss, Destin and Dunn, Inc.

    Peachtree City, GA 30269

    www.valuelabels.com

    1-866-696-0957

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    GOODSENSE ANTIBACTERIAL MOISTURIZING 
    benzalkonium chloride film
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-004-5940 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/21/2011
    Labeler - GEISS, DESTIN AND DUNN, INC. (076059836)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICAN HYGIENICS CORPORATION545198454manufacture
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