KENDALL MOISTURE BARRIER (DIMETHICONE) CREAM [COVIDIEN INC.]

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KENDALL MOISTURE BARRIER (DIMETHICONE) CREAM [COVIDIEN INC.]
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NDC 28851-693-01, 28851-693-02, 28851-693-03
Set ID a1d57cf3-fe5e-427e-8b43-38e01ab84936
Category HUMAN OTC DRUG LABEL
Packager Covidien Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active Ingredient

    Dimethicone 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 as needed
  • 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 alcohol, glyceryl stearate, cirtus aurantium bergamia (bergamot) fruit oil, citrus medica vulgaris peel oil, sodium stearoyl lactylate, retinyl palmitate, tocopheryl acetate, isopropyl palmitate, propylene glycol, triethanolamine, sodium PCA, carbopol, butyrospermum parkii (shea butter), phenoxyethanol, methylparaben, butylparaben, propylparaben, isobutylparaben, ethylparaben

  • QUESTIONS

    Questions or comments?  1-800-962-9888

  • PRINCIPAL DISPLAY PANEL


    Image of Kendall Moisture Barrier Cream 2 Fl oz Label

    Image of Kendall Moisture Barrier Cream 2 Fl oz Label

  • INGREDIENTS AND APPEARANCE
    KENDALL MOISTURE BARRIER 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28851-693
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone5.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ACETATE ION (UNII: 569DQM74SC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28851-693-0159 mL in 1 TUBE
    2NDC:28851-693-02118 mL in 1 TUBE
    3NDC:28851-693-034 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/21/2011
    Labeler - Covidien Inc. (805770828)
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