Label: HEMORRODIL UNGUENTO PLUS- hydrocortisone ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated March 11, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hydrocortisone (1%)

  • Purpose

    Anti-Itch

  • Uses

    Temporary relief of external anal itch & minor skin irritations and rashes.

  • Warnings

    For external use only.

    Do not use for treatment of diaper rash. Consult a doctor.

    When using this product: avoid contact with eyes, 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 symptoms persist for more than 7 days or clear up & occur again with a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

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

  • Instructions

    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 application of this product

    Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

    Children under 12 years of age

    Do not use, consult a doctor.

  • STORAGE AND HANDLING

    Store at room temperature or in cool place, but not over 80°F.

  • Inactive Ingredients

    Petrolato, benzocaína, mentol, metil paraben, propil paraben.

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    Net Weight: 15g

    HEMORRODIL Plus
    Relieves Pain & Itch

    HEMORRHOIDAL OINTMENT
    WITH HYDROCORTISONE 1%

    Principal Display Panel - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HEMORRODIL UNGUENTO PLUS 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-132
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOCAINE (UNII: U3RSY48JW5)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61357-132-011 in 1 CARTON
    115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY03/01/1964
    Labeler - ZURICH MEDICAL LABS, LLC (071904097)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZURICH MEDICAL LABS, LLC071904097MANUFACTURE(61357-132)
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