PREPARATION H OINTMENT - phenylephrine hydrochloride, mineral oil, petrolatum and shark liver oil ointment 
Wyeth Consumer Healthcare

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Preparation H Hemorrhoidal Ointment
(mineral oil, petrolatum, phenylephrine HCl, and shark liver oil)

DRUG FACTS

ACTIVE INGREDIENTS

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

Shark liver oil 3.0%

PURPOSES

Protectant

Protectant

Vasoconstrictor

Protectant

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
• regular use provides continual therapy for relief of symptoms
• children under 12 years of age: ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

benzoic acid, BHA, BHT, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, thyme oil, tocopherol, water, wax

QUESTIONS OR COMMENTS?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374 or visit us at www.preparationh.com

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

PREPARATION H HEMORRHOIDAL OINTMENT

Prevents Further Irritation

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 (57g)

Tamper-Evident: Do Not Use if tube seal under cap embossed with “H” is broken or missing.

Wyeth Consumer Healthcare

Madison, NJ 07940 Made in USA

PREPARATION H OINTMENT  mineral oil, petrolatum, phenylephrine hcl, shark liver oil   ointment

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2871 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 2.5 mg  in 1 g mineral oil (mineral oil) mineral oil 140 mg  in 1 g petrolatum (petrolatum) petrolatum 719 mg  in 1 g shark liver oil (shark liver oil) shark liver oil 30 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (smooth yellow ointment) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0573-2871-10 1 TUBE In 1 CARTON contains a TUBE 1 28 g In 1 TUBE This package is contained within the CARTON (0573-2871-10) 2 0573-2871-20 1 TUBE In 1 CARTON contains a TUBE 2 57 g In 1 TUBE This package is contained within the CARTON (0573-2871-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/01/2004

Labeler - Wyeth Consumer Healthcare (828831730)

Revised: 06/2009Wyeth Consumer Healthcare