Label: HEMORRODIL UNGUENTO- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 7, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide 5%

  • Categoría

    Astringent

  • Use

    For temporary relief of pain, soreness and burning. Helps relieve the local itching and discomfort. Temporarily shrinks hemorrhoidal tissue & provides a coating for relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

  • Warning

    For external use only.

    Do Not Use if: you are allergic to any ingredient in this formula. When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if: bleeding occurs; condition worsens or does not improve within 7 days; an allergic reaction develops; the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

    • If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults

    When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or a soft cloth before applying ointment. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.

  • DOSAGE & ADMINISTRATION

    For Intrarectal use: attach applicator to tube, lubricate applicator well, then gently insert applicator into the rectum; thoroughly cleanse applicator after each use and replace cover. Also apply ointment to external area.

    Children under 12 years of age: ask a doctor.

  • STORAGE AND HANDLING

    Store at 20-25°C (68°-77°F)

  • Other Ingredients

    Lanolin, petrolatum, purified H2O, peanut oil, witch hazel, cod liver oil, polysorbate 80, cethyl alcohol, bees wax, glycerin, stearate, menthol, methyl & propyl paraben, bálsamo de Perú

  • PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

    Refreshing & soothes the pain of hemorrhoids
    Net weight: 1oz (28.35g)

    zürich
    medical
    labs
    502 NE 190th St. • Miami, FL 33179

    Made in U.S.A.

    HEMORRODIL

    Hemorrhoidal Ointment

    Principal Display Panel - 28.35 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HEMORRODIL UNGUENTO 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-130
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WITCH HAZEL (UNII: 101I4J0U34)  
    PEANUT OIL (UNII: 5TL50QU0W4)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    MENTHOL (UNII: L7T10EIP3A)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61357-130-011 in 1 CARTON
    128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34603/01/1964
    Labeler - ZURICH MEDICAL LABS, LLC (071904097)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZURICH MEDICAL LABS, LLC071904097MANUFACTURE(61357-130)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!