Comfort Shield Barrier
dimethicone · Cloth · Topical
Active ingredient
Active Ingredient Dimethicone 3%
Purpose
Purpose Skin protectant
Uses
Uses helps seal out wetness helps treat and prevent perineal dermatitis protects from minor skin irritation associated with perineal dermatitis
Warnings
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
Stop use and ask a doctor
Stop use and consult a doctor if condition worsens or does not improve within 7 days
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
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
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?
Questions or Comments? 800-323-2220
Label text from the FDA structured product label by Sage Products LLC (revised Jun 23, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dimethicone in 1 product
Comfort Shield Barrier NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 53462-915 | Dimethicone 30 mg/g Cloth | Sage Products LLC | OTC MONOGRAPH DRUG |
Comfort Shield Barrier recalls
- D-0229-2017 Dec 28, 2016 · Class I · Terminated
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. - D-0230-2017 Dec 28, 2016 · Class II · Terminated
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. - D-1573-2014 Sep 10, 2014 · Class II · Terminated
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Frequently asked questions
What is Comfort Shield Barrier used for?
Uses helps seal out wetness helps treat and prevent perineal dermatitis protects from minor skin irritation associated with perineal dermatitis
Who makes Comfort Shield Barrier?
Comfort Shield Barrier is listed by 1 labeler in the FDA NDC directory, including Sage Products LLC.
Has Comfort Shield Barrier been recalled?
The FDA enforcement database lists 3 recalls for Comfort Shield Barrier, most recently D-0229-2017 (class i): Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.