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PREPARATION H by Pfizer Consumer Healthcare

Dosage form: ointment
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g, MINERAL OIL 140mg in 1g, PETROLATUM 749mg in 1g
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-2871

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.

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

DRUG FACTS

ACTIVE INGREDIENTS

Mineral oil 14%

Petrolatum 74.9%

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

QUESTIONS OR COMMENTS?

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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

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 1 OZ (28 g)

PREPARATION H 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2871
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
MINERAL OIL (MINERAL OIL) MINERAL OIL140 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM749 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
CORN OIL 
GLYCERIN 
LANOLIN 
LANOLIN ALCOHOLS 
METHYLPARABEN 
PARAFFIN 
PROPYLPARABEN 
WATER 
THYME 
WHITE WAX 
Product Characteristics
ColorYELLOW (smooth yellow ointment) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-2871-101 TUBE in 1 CARTON
128 g in 1 TUBE
2NDC:0573-2871-201 TUBE in 1 CARTON
257 g in 1 TUBE
3NDC:0573-2871-042 CARTON in 1 PACKAGE
3NDC:0573-2871-201 TUBE in 1 CARTON
357 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34603/01/2004
Labeler - Pfizer Consumer Healthcare (828831730)

Revised: 09/2014
 
Pfizer Consumer Healthcare

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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