3M CAVILON DURABLE BARRIER (DIMETHICONE) CREAM [3M HEALTH CARE]

3M CAVILON DURABLE BARRIER (DIMETHICONE) CREAM [3M HEALTH CARE]
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NDC 17518-030-01, 17518-030-02, 17518-030-03
Set ID f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83
Category HUMAN OTC DRUG LABEL
Packager 3M Company
Generic Name
Product Class
Product Number
Application Number PART347
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone 1.3%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin
  • Warnings

    • For external use only
    • Avoid contact with eyes

    • Stop use and ask a doctor if
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    • Do not use on
    • deep or puncture wounds
    • animal bites
    • serious burns

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

    • Apply as needed
    • Gently cleanse skin as required
    • Apply cream sparingly to cover the entire affected area
    • Note: If the feel is oily, too much has been applied
  • Inactive ingredients

    Acrylate Terpolymer, Benzoic Acid, Cocos Nucifera (Coconut) Oil, Dehydroacetic Acid, Diisooctyl Adipate, Glycerin, Isopropyl Palmitate, Magnesium Sulphate, Mineral Oil, Paraffin, Phenoxyethanol, PPG-15 Stearyl Ether, Trimethylsiloxysilicate, Water

  • Questions?

    Call 1-800-228-3957 (Monday to Friday 7AM  6PM CST)

  • Principal Display Panel – 28 g Tube Label

    LOT

    EXP

    3M™

    NDC 17518-030-02

    Cavilon™

    Durable Barrier

    Cream

    • Protects and moisturizes skin
    • Durable, long lasting formula
    • Breathable
    • Allows tape to adhere
    • CHG compatible
    • Fragrance free

    Not made with Natural Rubber Latex

    Active Ingredient made in U.S.A.

    ©3M 2015, All rights reserved.

    3M and Cavilon are trademarks of 3M

    REF

    3354

    Net Weight 1 oz. • 28g

    Active Ingredient made in U.S.A.

    ©3M 2015, All rights reserved.

    3M and Cavilon are trademarks of 3M

    Made in the U.K. by

    3M Health Care

    2510 Conway Ave

    St. Paul, MN 55144

    3M.com/Cavilon

    Principal Display Panel – 28 g Tube Label
  • INGREDIENTS AND APPEARANCE
    3M CAVILON DURABLE BARRIER 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17518-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone13000 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Dehydroacetic Acid (UNII: 2KAG279R6R)  
    Diisooctyl Adipate (UNII: 2TLQ9O0CWB)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Magnesium Sulfate Heptahydrate (UNII: SK47B8698T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    PPG-15 Stearyl Ether (UNII: 1II18XLS1L)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17518-030-030.00126 L in 1 TUBE; Type 0: Not a Combination Product06/01/2016
    2NDC:17518-030-020.000383 L in 1 TUBE; Type 0: Not a Combination Product06/01/2016
    3NDC:17518-030-010.0000273 L in 1 PACKET; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2016
    Labeler - 3M Company (006173082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kindeva Drug Delivery Limited225650929MANUFACTURE(17518-030) , LABEL(17518-030) , PACK(17518-030)