Medichoice Barrier Cloth
FDA Label NDC 39892-0950
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O&m Halyard, Inc. for the product Medichoice Barrier (NDC 39892-0950). 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 drug facts, active ingredient, purpose, uses, warnings, stop use and consult a doctor, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
If Heating Is Desired:
• Tear open package, heat entire package in microwave for no longer than 18 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:
Label0 (Label0)
Label02 (Label02)
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