HEMORRODIL UNGUENTO- zinc oxide ointment 
ZURICH MEDICAL LABS, LLC

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.

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Hemorrodil Unguento

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.

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.

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
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)

Revised: 3/2014
Document Id: 0639fa84-e31c-45f7-ad6a-cae2099e321b
Set id: 0bde2cef-663b-4893-b322-21b2a29c5687
Version: 1
Effective Time: 20140307
 
ZURICH MEDICAL LABS, LLC