Label: 3M CAVILON DURABLE BARRIER- dimethicone cream

  • NDC Code(s): 17518-030-01, 17518-030-02, 17518-030-03
  • Packager: 3M Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 21, 2022

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  • 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)

    34-8726-1561-1

  • Principal Display Panel – 28 g Tube Label

    LOT

    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 2020, All rights reserved.

    3M and Cavilon are trademarks of 3M

    REF

    3354

    Net Weight 1 oz • 28g

    Made in the USA with globally sourced materials

    3M Company

    2510 Conway Ave

    St. Paul, MN 55144

    3M.com

    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)
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