FDA Label for Medichoice Barrier

View Indications, Usage & Precautions

Medichoice Barrier Product Label

The following document was submitted to the FDA by the labeler of this product Owens & Minor Distribution, Inc.. 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.

Drug Facts




Active Ingredient



Dimethicone 3.2%


Purpose



Skin Protectant


Uses



• Temporarily protects and helps relieve chapped or cracked skin
• Helps prevent perineal dermatitis • Protects from minor skin irritation associated with perineal dermatitis


Warnings



For external use only. 
Keep out of eyes, ears and mouth.


Stop Use And Consult A Doctor



if condition worsens or does not improve within 7 days.


Keep Out Of Reach Of Children



except with adult supervision. 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 wipe after use. • Do not flush. • For individual use only. • Reseal label between uses.


If Heating Is Desired:



• Peel open label without completely removing it, heat entire package in microwave for no longer than 45 seconds. Check the temperature of cloths as microwave wattage varies. May also used at room temperature. • Ensure temperature of washcloths is not excessively hot. Gloves diminish sensitivity to heat. Closely monitor heat level with infants, unresponsive or skin sensitive individuals.


Inactive Ingredients



Aqua, Glycerin, Cetearyl Alcohol, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Capryly Glycol, Xanthan Gum


Package Labeling:




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