Label: HEMORRHOID, FISSURE, PROCTALGIA OINTMENTS- carbon, mirabilite, peppermint oil, borneol, glycerin salve

  • NDC Code(s): 84533-003-01
  • Packager: WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 19, 2024

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  • ACTIVE INGREDIENT

    Carbon 1%
    Mirabilite 2%
    Peppermint oil 0.2%
    Borneol 3%
    Glycerin 8%

  • PURPOSE

    Adsorbent and detoxifying
    Anti-infmmatoty and soothing
    cooling and analgesic
    Analgesic and anti-infiommatoey
    Humectant and moistueizing

  • 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

  • PRINCIPAL DISPLAY PANEL

    labellabel2

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID, FISSURE, PROCTALGIA OINTMENTS 
    carbon, mirabilite, peppermint oil, borneol, glycerin salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84533-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL1 g  in 100 g
    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
    Inactive Ingredients
    Ingredient NameStrength
    PEG-23 STEARATE (UNII: RCE8XV9D25)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84533-003-017 g in 1 BOX; Type 0: Not a Combination Product08/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01508/06/2024
    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(84533-003)
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