Label: COMFORT SHIELD BARRIER- dimethicone cloth

  • NDC Code(s): 53462-915-24, 53462-915-50, 53462-915-51, 53462-915-62, view more
    53462-915-80, 53462-915-81
  • Packager: Sage Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

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  • Active Ingredient

    Dimethicone 3%

  • Purpose

    Skin protectant

  • Uses

    • helps seal out wetness
    • helps treat and prevent perineal dermatitis
    • protects from minor skin irritation associated with perineal dermatitis
  • Warnings

    For external perineal use only. 
    Avoid contact with the eyes.

    Stop use and consult a doctor if condition worsens or does not improve within 7 days

    Keep out of reach of children.

    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 cloth after use - DO NOT FLUSH CLOTHS
    • use as often as necessary, especially if prolonged exposure to wetness is anticipated
    • for individual use only
    • reseal label between uses
    • discard package immediately if cloths are dry

    If warming is desired:

    • peel open label without completely removing it
    • heat entire package in microwave no longer than [see package for time].
    • since microwave wattage varies, adjust heating time accordingly
    • Comfort Shield® may also be used at room temperature or warmed in a Comfort Personal Cleansing Warmer.
    • Caution: If there is any indication barrier cloths are excessively hot, do not use
    • Remember, gloves diminish your sensitivity to heat
    • Closely monitor heat level with infants, unresponsive or skin sensitive individuals
  • Inactive Ingredients

    Water, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, cetyl alcohol, glycerin, stearyl alcohol, phenoxyethanol, methylpropanediol, chlorhexidine gluconate, hydroxyethyl cellulose, ethylhexylglycerin, polyquaternium-37, propylene glycol dicaprylate/dicaprate, glucono-delta-lactone, PPG-1 trideceth-6

    Barrier cloths: cellulose fiber/polyester (PET) fiber

  • Questions or Comments?

    800-323-2220

  • Comfort Shield Barrier

    R4157N_7905R5474B_ShieldR5545_7905R5549_7503R6223B_7924R5548_7502R6110C_ShieldR5567C_7924

  • INGREDIENTS AND APPEARANCE
    COMFORT SHIELD BARRIER 
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-915
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-915-503 in 1 PACKAGE01/01/1990
    126 g in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:53462-915-513 in 1 PACKAGE01/01/1990
    219 g in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:53462-915-6224 in 1 PACKAGE01/01/199009/21/2016
    324 g in 1 APPLICATOR; Type 0: Not a Combination Product
    4NDC:53462-915-808 in 1 PACKAGE01/01/1990
    427 g in 1 APPLICATOR; Type 0: Not a Combination Product
    5NDC:53462-915-818 in 1 PACKAGE01/01/1990
    519 g in 1 APPLICATOR; Type 0: Not a Combination Product
    6NDC:53462-915-2424 in 1 PACKAGE12/11/2023
    624 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/01/1990
    Labeler - Sage Products LLC (054326178)
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