Otc - Active Ingredient
Hypochlorous Acid
Mediaqua Premium
FDA Label NDC 80458-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mediecotech Co Ltd for the product Mediaqua Premium (NDC 80458-0001). 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, indications & usage, warnings, dosage & administration, 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
WATER, sodium chloride
Otc - Purpose
sterilization, disinfection
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF THE CHILDREN
Indications & Usage
Apply an appropriate amount on your hands and rub well to dry.
Warnings
1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms
Dosage & Administration
for external use only
Package Label.Principal Display Panel
Label (Label)
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