FDA Label for Preparation H Maximum Strength

Other

Drug Facts

Otc - Purpose

Uses

• for temporary relief of pain, soreness and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• 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 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

Otc - Ask Doctor/Pharmacist

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
• 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 cream.
• when first opening the tube, puncture foil seal with top end of cap
• apply externally or in the lower portion of the anal canal only
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
• thoroughly cleanse dispensing cap after each use and replace cover
• children under 12 years of age: ask a doctor

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

Questions Or Comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374.

For most recent product information, visit www.preparationh.com.

Principal Display Panel - 51 G Tube Carton

PREPARATION H^®
HEMORRHOIDAL CREAM

Maximum Strength Pain Relief

Smooth Cream
Formula with Aloe

• Rapid, Soothing Pain Relief from Painful
  Burning, Itching and Discomfort
• Shrinks Swollen Hemorrhoidal Tissue
• Protects Irritated Tissue
• Relieves External Discomfort

NET WT. 1.8 OZ (51 g)

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - preparation h 01