PREPARATION H CREAM MAX STRENGTH description, usages, side effects, indications, overdosage, supplying and lots more!

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PREPARATION H CREAM MAX STRENGTH

Pfizer Consumer Healthcare

Preparation H Maximum Strength Cream(glycerin, phenylephrine HCl, pramoxine HCl, and white petrolatum)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

PURPOSES

Protectant

Vasoconstrictor

Local anesthetic

Protectant

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

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

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 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.

PRODUCT PACKAGING

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

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)

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

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

Wyeth Consumer Healthcare

Madison, NJ 07940 USA © 2009 Wyeth

PREPARATION H CREAM MAX STRENGTH

PREPARATION H CREAM MAX STRENGTH

glycerin, petrolatum, phenylephrine HCl, pramoxine HCl CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2868
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GLYCERIN 144 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
pramoxine hydrochloride PRAMOXINE 10 mg
petrolatum 150 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 26 in 1 TUBE
2 51 in 1 TUBE
3 NDC:0573-2868-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2004-07-01


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