Label: COMFORT SHIELD BARRIER- dimethicone cloth

  • NDC Code(s): 53462-915-50, 53462-915-51, 53462-915-62, 53462-915-80, view more
    53462-915-81
  • Packager: Sage Products LLC
  • 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 February 22, 2022

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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

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  • 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 PACKAGE01/01/1990
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/1990
    Labeler - Sage Products LLC (054326178)