Otc - Active Ingredient
Hydrocolloid
Drmitsui Hydrocolloid Wound Patch
FDA Label NDC 87267-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yiyangyuan Life Sciences (hong Kong) Co., Limited for the product Drmitsui Hydrocolloid Wound (NDC 87267-012). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
PRODUCT COMPOSITION: Outer layer substrate, Hydrocolloid, Protective layer.
Otc - Purpose
SOOTHING GEL
ACTIVATIONADVANCED MOISTURE CONTROL
PROTECTIVE & HYGIENIC BARRIER
HEALING-OPTIMIZED MICROCLIMATE
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Warnings
Do not use if you have a known allergy to hydrocolloids.oDiscontinue use immediately if you experience any discomfort during use.This product is a daily-use item and is not intended to replace medications ormedical devices.
Dosage & Administration
This is a single-use product; use as soon as possible afteropening the package. Do not use if you have a known allergy to hydrocolloids.oDiscontinue use immediately if you experience any discomfort during use.This product is a daily-use item and is not intended to replace medications ormedical devices.
Indications & Usage
Wash your hands thoroughly before and after treating the woundresidue before application. Ensure that the wound area is clean, dry, and freefrom any oily. Remove the release paper from the dressing. Maintain the adhesiveside of the dressing facing the wound. Accurately align the dressing, ensuringthe wound is situated at the centre. Apply dressing gently over the wound.oRemove the remaining clear release film (marked by arrows) from the dressing,and careful smooth it into place.
Package Label.Principal Display Panel
Labeling (87267 012 01)
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