Otc - Active Ingredient
Carbon 1%
Mirabilite 2%
Peppermint oil 3%
Borneol 0.2%
Glycerin 8%
Hemorrhoid, Fissure, Proctalgiasuppositories Suppository
FDA Label NDC 84533-001
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, Proctalgiasuppositories (NDC 84533-001). 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, storage and handling, inactive ingredient, 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-inflammatory and soothing
Cooling and analgesic
Analgesic and anti-inflammatery
Humectant and moisturizing
Otc - Keep Out Of Reach Of Children
Keep out of reach ofchildren.
lf swallowed, seek medicalhelp or contact a PolsonControl Center right away.
Indications & Usage
temporarily protects the inflamed, irritatedanorectal surface to help make bowel movementsless painful from irritation and abrasion duringbowel movement
*provides temporary relief of pain, soreness, orburning*helps relieve the local or anorectal itching anddiscomfort associated with hemorrhoids
Warnings
For external and/or intrarectal use.
Dosage & Administration
adults and children 12 years of age and over:when practical, cleanse area with mild soap andwarm water and rinse thoroughly.Gently dry bypatting or blotting with toilet tissue or a soft clothbefore applying.Apply to the affected area up to 4 times daily,especially at night, in the morning or after eachbowel movement.For intrarectal use: after wetting, apply around theanal area and then insert into the rectum..children under 12 years of age: ask a doctor
Storage And Handling
Additionalinformation:store in a cool, dry place.It is recommended tostore below 68°F(20°C)Refrigeration is advised.
Inactive Ingredient
Polyethylene Glycol
POLYSORBATE 60
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Label (Label)
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