HEMORRODIL UNGUENTO- zinc oxide ointment

Hemorrodil Unguento by

Drug Labeling and Warnings

Hemorrodil Unguento by is a Otc medication manufactured, distributed, or labeled by ZURICH MEDICAL LABS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HEMORRODIL UNGUENTO 
zinc oxide ointment

Product 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)