Label: KENDALL 2-IN-1 CLEANSER- dimethicone liquid

  • Category: HUMAN OTC DRUG LABEL

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

    Dimethicone 1.5%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Use

    temporarily protects chapped or cracked 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
    • symptoms last more than seven days or clear up and occur again within a few 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

    • apply cleanser to cloth or directly to the skin
    • gently wipe clean.  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, simmondsia chinensis (jojoba) seed oil, zea mays (corn) starch, cetearyl isononanoate, ceteareth-20, glycerin, cetearyl alcohol, glyceryl stearate, cetyl palmitate, cirtus aurantium bergamia (bergamot) fruit oil, citrus medica vulgaris peel oil, ceteareth-12, retinyl palmitate, tocopheryl acetate, PPG-2 hydroxyethyl coco/isostearamide, acrylates/c10-30 alkyl acrylate crosspolymer, sodium hydroxide, phenoxyethanol, methylparaben, butylparaben, propylparaben, isobutylparaben, ethylparaben

  • QUESTIONS

    Questions or comments?  1-800-962-9888

  • PRINCIPAL DISPLAY PANEL


    Image of 4 Ounce Label

    Image of Kendall 2-in-1 Cleanser Label

  • INGREDIENTS AND APPEARANCE
    KENDALL 2-IN-1 CLEANSER 
    dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28851-690
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ACETATE ION (UNII: 569DQM74SC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28851-690-01118 mL in 1 BOTTLE, SPRAY
    2NDC:28851-690-02236 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/05/2011
    Labeler - Covidien Inc. (805770828)
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