Otc - Active Ingredient
Phenylephrine HCI 0.25% ,
Witch hazel 50%.
Drmitsui Medical Haemorrhoid Gel
FDA Label NDC 87267-011
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 Medical Haemorrhoid (NDC 87267-011). 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, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, 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
Otc - Purpose
ANAL DISTENDING PAIN.
MUCOSAL CONGESTION.
PROLAPSE OF HAEMORRHOIDS
INTERNAL & MIXED HAEMORRHOIDS.
Otc - Keep Out Of Reach Of Children
Keep Out of reach of children
Warnings
WARNINGS
For external use only.
Dosage & Administration
Apply externally to the affectedarea up to 4 times daily, especiallyat night, in the morning or aftereach bowel movement
Indications & Usage
Swith an appropriate cleansing wipe.Gently dry by patting or blotting witha tissue or a soft cloth before applyinggel. When first opening the tube,puncture foil seal with topend of cap..Apply externally to the affectedarea up to 4 times daily, especiallyat night, in the morning or aftereach bowel movement..Childrenunder 12 years of age: ask a doctor.
Inactive Ingredient
Carbomer, Glycerol, Hydroxybenzoate ethyl ester, Triethanolamine, Purified water.
Package Label.Principal Display Panel
Labeling (85031 011 01)
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