Label: HEMORRODIL UNGUENTO- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 61357-130-01 - Packager: ZURICH MEDICAL LABS, LLC
- 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.
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Categoría
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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
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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.
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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
- STORAGE AND HANDLING
- Other Ingredients
- PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton
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INGREDIENTS AND APPEARANCE
HEMORRODIL UNGUENTO
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61357-130 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 50 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61357-130-01 1 in 1 CARTON 1 28.35 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 03/01/1964 Labeler - ZURICH MEDICAL LABS, LLC (071904097) Establishment Name Address ID/FEI Business Operations ZURICH MEDICAL LABS, LLC 071904097 MANUFACTURE(61357-130)