Label: MEDICHOICE BARRIER- dimethicone cloth

  • NDC Code(s): 39892-0951-1, 39892-0951-2
  • 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. • Reseal label between uses.

  • If heating is desired:

    • Peel open label without completely removing it, heat entire package in microwave for no longer than 45 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:

    Label03

  • Package Labeling:

    Label04

  • INGREDIENTS AND APPEARANCE
    MEDICHOICE BARRIER 
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0951
    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:39892-0951-18 in 1 PACKAGE01/25/2024
    120 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:39892-0951-28 in 1 CASE01/25/2024
    230 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 DrugOKM01601/25/2024
    Labeler - Owens & Minor Distribution, Inc. (847412269)
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