Comfort Shield Barrier Cloth
FDA Label NDC 53462-915

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sage Products Llc for the product Comfort Shield Barrier (NDC 53462-915). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, if warming is desired:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ If Warming Is Desired:

→ Inactive Ingredients

→ Questions Or Comments?

→ Comfort Shield Barrier

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.

Otc - Stop Use

Stop use and consult a doctor if condition worsens or does not improve within 7 days

Otc - 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

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