SWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]

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SWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]
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NDC 11701-063-70, 11701-063-71, 11701-063-72, 11701-063-73
Set ID a623c8d7-8db0-410a-9980-02ac02f7b6ea
Category HUMAN OTC DRUG LABEL
Packager Coloplast Manufacturing US, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone, 6%

  • Purpose

    Skin Protectant

  • Uses

    Helps prevent and temporarily protects chafed, chapped or cracked skin and lips.

  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • Do not get into eyes

    Stop using this product if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

    Keep this and all drugs out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • apply as needed
  • Inactive ingredients

    behentrimonium methosulfate, cetearyl alcohol, ethylhexyl palmitate, glycerin, isopropyl palmitate, PEG-5 ditrimethylolpropane tetrahydroxystearate, PEG-150 pentaerythrityl tetrastearate, water

  • Questions or comments?

    Call toll free 1-800-533-0464

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Coloplast A/S, Holtedam 1,
    DK-3050 Humlebaek, Denmark
    Distributed by: Coloplast Corp, 1601 W River Rd N,
    Minneapolis, MN 55411 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Label

    NDC 11701-063-73

    Sween® 24

    Moisturizer
    Once a Day
    Moisturizing
    Body Cream

    For Normal to Dry,
    Flaky, Itchy Skin

    Product #7091

    Coloplast

    NET WT. 2 OZ. (57 g)

    PRINCIPAL DISPLAY PANEL - 57 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SWEEN 24 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-063-71142 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    2NDC:11701-063-70256 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    3NDC:11701-063-7357 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    4NDC:11701-063-724 g in 1 PACKET; Type 0: Not a Combination Product06/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-063)
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