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Comfort Shield Barrier

Dosage form: cloth
Ingredients: dimethicone 756mg
Labeler: Sage Products LLC
NDC Code: 53462-915

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 Facts

Active Ingredient

Dimethicone 3%


Skin protectant

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


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

  • remove wet and soiled garment
  • cleanse soiled area using a fresh barrier cloth
  • use as often as necessary, especially if prolonged exposure to wetness is anticipated
  • for individual use only
  • reseal label between uses
  • discard immediately if barrier cloths are dry

If heating is desired:
  • peel open label without completely removing it
  • heat entire package in microwave for no longer than 45 seconds
  • since microwave wattage varies, adjust heating time accordingly
  • Comfort Shield® may also be used at room temperature
  • 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, glycerin, PPG-15 stearyl ether, glyceryl stearate, PEG-100 stearate, stearic acid, aloe barbadensis gel, stearyl alcohol, chlorhexidine gluconate, hydroxyethyl cellulose, methylparaben, propylparaben

barrier cloths: cellulose fiber/polyester (PET) fiber, 8.5" x 8.5"

Questions or Comments?


dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-915
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimethicone (dimethicone) dimethicone756 mg
Inactive Ingredients
Ingredient NameStrength
glyceryl monostearate 
PEG-100 stearate 
stearic acid 
aloe vera leaf 
stearyl alcohol 
chlorhexidine gluconate 
hydroxyethyl cellulose (4000 MPA.S at 1%) 
#Item CodePackage Description
1NDC:53462-915-503 CLOTH in 1 PACKAGE
2NDC:53462-915-513 CLOTH in 1 PACKAGE
3NDC:53462-915-6024 CLOTH in 1 PACKAGE
4NDC:53462-915-6224 CLOTH in 1 PACKAGE
5NDC:53462-915-808 CLOTH in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/1990
Labeler - Sage Products LLC (054326178)
Sage Products LLC054326178MANUFACTURE(53462-915)

Revised: 07/2015
Sage Products LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.