FDA Label for Comfort Shield Barrier
View Indications, Usage & Precautions
Comfort Shield Barrier Product Label
The following document was submitted to the FDA by the labeler of this product Sage Products Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Questions Or Comments?
800-323-2220
Comfort Shield Barrier
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