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PREPARATION H MAXIMUM STRENGTH

Medically reviewed on October 16, 2017

Dosage form: cream
Ingredients: GLYCERIN 144mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g, PETROLATUM 150mg in 1g
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-2868

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® MAXIMUM STRENGTH

Drug Facts

Active ingredientsPurposes
Glycerin 14.4%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor
Pramoxine HCl 1%Local anesthetic
White petrolatum 15%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.

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)

PREPARATION H   MAXIMUM STRENGTH
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2868
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN144 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
ANHYDROUS CITRIC ACID 
BUTYLATED HYDROXYANISOLE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
DEXPANTHENOL 
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
LAURETH-23 
METHYLPARABEN 
MINERAL OIL 
PROPYL GALLATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM BENZOATE 
STEARYL ALCOHOL 
WATER 
XANTHAN GUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-2868-101 TUBE in 1 CARTON
126 g in 1 TUBE
2NDC:0573-2868-201 TUBE in 1 CARTON
251 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34607/01/2004
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Pfizer Canada Inc.246770197ANALYSIS(0573-2868), LABEL(0573-2868), MANUFACTURE(0573-2868), PACK(0573-2868)

 
Pfizer Consumer Healthcare

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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