Otc - Active Ingredient
mineral oil, petrolatum
Elgoalin Hiseng
FDA Label NDC 82677-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elgoalin Bio Co.,ltd for the product Elgoalin Hiseng (NDC 82677-0001). 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
aloe barbadensis leaf extract, matricaria flower extract, sunflower seed oil, glycerin, butlyne glycol
Otc - Purpose
■ temporarily protects irritated areas ■ temporarily relieves burning ■ temporarily protects inflamed anorectal skin ■ temporarily relieves the symptoms of anorectal skin irritation
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
■ spray liverally to the affected area as necessary
Warnings
For external use only
When using this product
■ do not exceed the recommended daily dosage unless directly by a doctor
■ do not put into the rectum by using fingers or any mechanical device or applicator ■ avoid contact with eyes ■ rinse with water to remove ■ do not swallow ■ do not store at temperature above 120 degree F
Dosage & Administration
for external use only
Package Label.Principal Display Panel
Label (Label)
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