Otc - Active Ingredient
Carbon 1%
Mirabilite 2%
Peppermint oil 0.2%
Borneol 3%
Glycerin 8%
Hemorrhoid, Fissure, Proctalgia Ointments Salve
FDA Label NDC 84533-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wu Xi Zhong Zhi Wei Na Technology Co., Ltd. for the product Hemorrhoid, Fissure, Proctalgia Ointments (NDC 84533-003). 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, indications & usage, warnings, dosage & administration, 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
Adsorbent and detoxifying
Anti-infmmatoty and soothing
cooling and analgesic
Analgesic and anti-infiommatoey
Humectant and moistueizing
Otc - Keep Out Of Reach Of Children
Keep out of reaah of children.
if swallowed, seek medical help or contact a poison control center right away.
Indications & Usage
instantly heips relieve anorectai itching and discomfort such as pain, sore-ness or burning commonlyassociated with hemorhoids.
tomporarily protects the inflamed, irritated anorectal area to make futurebowei mowements less painfut from irritation and abrasion.
Warnings
For eoternat and/or intrarectal use.
Dosage & Administration
.aduits and chlkdren 12 years of oage and oer when practical,cleanse area with mild soap and warm water and rinsethorcughiy, Gently dry by patting or blotting with tollet tissue ora sodt cloth before applying.Apply to the atfected area up to 4 times daily, cspecially atnight, in the moming or after each bowei movement.For intrarectaluse: after watting, apply around the anad creaand then insert tip into tho reatum, then use provided oowerpads.
. children under 12 yoars cf age ask a doctor
Inactive Ingredient
Polyethylene Glycol
Polyoxyethylene (40) Stearate
Package Label.Principal Display Panel
Label (Label1)
Label2 (Label2)
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