Label: MEDICHOICE BARRIER- dimethicone cloth

  • NDC Code(s): 39892-0950-1, 39892-0950-2
  • Packager: Owens & Minor Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 14, 2024

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  • Drug Facts

  • Active ingredient

    Dimethicone 3.2%

    Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin
    • Helps prevent perineal dermatitis • Protects from minor skin irritation associated with perineal dermatitis

  • Warnings

    For external use only.
    Keep out of eyes, ears and mouth.

    Stop use and consult a doctor

    if condition worsens or does not improve within 7 days.

    Keep out of reach of children

    except with adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Remove wet and soiled garment. • Cleanse soiled area using a fresh barrier cream cloth. • Discard wipe after use. • Do not flush. • For individual use only.

  • If heating is desired:

    • Tear open package, heat entire package in microwave for no longer than 18 seconds. Check the temperature of cloths as microwave wattage varies. May also used at room temperature. • Ensure temperature of washcloths is not excessively hot. Gloves diminish sensitivity to heat. Closely monitor heat level with infants, unresponsive or skin sensitive individuals.

  • Inactive ingredients

    Aqua, Glycerin, Cetearyl Alcohol, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Capryly Glycol, Xanthan Gum

  • Package Labeling:

    Label0

  • Package Labeling:

    Label02

  • INGREDIENTS AND APPEARANCE
    MEDICHOICE BARRIER 
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE32 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39892-0950-13 in 1 PACKAGE01/25/2024
    120 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:39892-0950-272 in 1 CASE01/25/2024
    2216 in 1 PACKAGE
    220 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/25/2024
    Labeler - Owens & Minor Distribution, Inc. (847412269)
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