Label: HEMORRHOID, FISSURE, PROCTALGIASUPPOSITORIES- carbon, mirabilite, peppermint oil, borneol suppository

  • NDC Code(s): 84533-001-01
  • Packager: WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2024

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  • ACTIVE INGREDIENT

    Carbon 1%
    Mirabilite 2%
    Peppermint oil 0.2%
    Borneol 3%

    Glycerin 8%

  • PURPOSE

    Adsorbent and detoxifying
    Anti-inflammatory and soothing
    Cooling and analgesic
    Analgesic and anti-inflammatery
    Humectant and moisturizing

  • 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

  • PRINCIPAL DISPLAY PANEL

    labellabel2

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID, FISSURE, PROCTALGIASUPPOSITORIES 
    carbon, mirabilite, peppermint oil, borneol suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84533-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.2 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN8 g  in 100 g
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL1 g  in 100 g
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE2 g  in 100 g
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84533-001-017 g in 1 BOX; Type 0: Not a Combination Product07/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01507/17/2024
    Labeler - WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. (412779339)
    Establishment
    NameAddressID/FEIBusiness Operations
    WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.412779339manufacture(84533-001)
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