Mineral Oil, Petrolatum and Phenylephrine HCl

Axcentria Pharmaceuticals, LLC

Hemorrhoidal Ointment

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENTS
• PURPOSES
• USES
• WARNINGS
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• DIRECTIONS
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS?
• PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton

FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

PURPOSES

Protectant

Protectant

Vasoconstrictor

USES

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue and relieves burning
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS

For external and/or intrarectal use only

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression.

When using this product

do not exceed the recommended daily dosage unless directed by a doctor.

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days
• introduction of applicator into the rectum causes additional pain

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 a tissue or a soft cloth before applying ointment.
• when first opening the tube, puncture foil seal with top end of cap
• apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• intrarectal use:
  • remove cover from applicator, attach applicator to tube, lubricate applicator well and 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

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

QUESTIONS?

To report adverse drug event call: (800) 616-2417

PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton

HEMORRHOIDAL
OINTMENT

TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

• Prompt, Soothing Relief from painful burning, itching and discomfort
• Shrinks swollen hemorrhoidal tissue
• Protects irritated tissue
• Relieves internal and external discomfort

NET WT 2 OZ (56.8 g)