Comfort Shield Barrier

Comfort Shield Barrier is an FDA-registered drug product whose active ingredient is DIMETHICONE. It is labelled by Sage Products LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 53462-915, application M016, label effective 20260623. It is one of 30 FDA drug label records sharing the active ingredient DIMETHICONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIMETHICONE are most often described in connection with: perineal dermatitis, helps seal, minor skin, irritation associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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

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

FDA lists 30 drug label records with DIMETHICONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

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?
Sage Products LLC is the labeler of record for Comfort Shield Barrier. 30 FDA label records share the active ingredient DIMETHICONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Comfort Shield Barrier come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Comfort Shield Barrier prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIMETHICONE?
Yes. 30 FDA drug label records list DIMETHICONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Comfort Shield Barrier been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.