Label: KENDALL ANTIMICROBIAL CLEANSER- benzalkonium chloride liquid

  • 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 5, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use

    • a no-rinse topical antiseptic that protects against microbial contamination
    • ideal for chapped or lightly traumatized skin
  • WARNINGS

    Warnings

    For external use only.
    When using this product 
    • do not get into eyes
    Do not use on 
    • deep or puncture wounds
    • animal bites
    • serious burns
    Stop use and ask a doctor if condition worsens or symptoms last more than seven days.

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


  • KEEP OUT OF REACH OF CHILDREN


  • DOSAGE & ADMINISTRATION

    Directions

    • spray soiled or odorous areas
    • gently wipe clean. Repeat as necessary.
    • pat dry.  No rinse necessary.
    • apply Kendall Moisturizing Lotion, Moisture Barrier Cream or Soothing Ointment as necessary
  • SPL UNCLASSIFIED SECTION

    Other Information

    • protect from freezing
    • avoid excessive heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Polysorbate 20, linoleamidopropyl PG-dimonium chloride phosphate, propylene glycol, cirtus aurantium bergamia (bergamot) fruit oil, citrus medica vulgaris peel oil, retinyl palmitate, tocopheryl acetate, methylparaben, propylparaben, diazolidinyl urea

  • QUESTIONS

    Questions or comments?  1-800-962-9888

  • PRINCIPAL DISPLAY PANEL

    Image of 4 Ounce Label

    Image of Kendall Antimicrobial Cleanser Label

  • INGREDIENTS AND APPEARANCE
    KENDALL ANTIMICROBIAL CLEANSER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28851-691
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ACETATE ION (UNII: 569DQM74SC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28851-691-01118 mL in 1 BOTTLE, SPRAY
    2NDC:28851-691-02236 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2011
    Labeler - Covidien Inc. (805770828)
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