COMFORT SHIELD BARRIER- dimethicone cloth 
Sage Products LLC

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Comfort Shield Barrier Cream Cloths

Active Ingredient

Dimethicone 3%

Purpose

Skin protectant

Uses

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

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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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)

Revised: 12/2023
Document Id: 0bdba093-da8e-673e-e063-6394a90a2cbf
Set id: cc08f571-84ae-4c2f-b09d-a83a8efc39f5
Version: 14
Effective Time: 20231206
 
Sage Products LLC