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Preparation H by Pfizer Consumer Healthcare

Medically reviewed on August 28, 2017

Dosage form: kit
Ingredients: COCOA BUTTER 2211mg, PHENYLEPHRINE HYDROCHLORIDE 6.25mg; WITCH HAZEL 5g
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-2884

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®

Preparation H® Suppositories

Drug Facts

Active ingredientsPurposes
Cocoa butter 88.44%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily relieves burning and 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 rectal 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

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 insertion of this product.
  • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
    • hold suppository with rounded end up
    • as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"
    • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
    • remove exposed suppository from wrapper
    • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement

  • children under 12 years of age: ask a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, methylparaben, propylparaben

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

Preparation H® Totables® Irritation Relief Wipes

Drug Facts

Active ingredient

Witch hazel 50.0%

Purpose

Astringent

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • aids in protecting irritated anorectal areas

Warnings

For external use only

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product 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

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: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
  • children under 12 years of age: consult a doctor

Other information
  • store at 20-25°C (68-77°F)
  • for best results, flush only one or two wipes at a time

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

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 - Kit Carton

SAME AMOUNT
Smaller Package

PREPARATION H®
HEMORRHOIDAL
SUPPOSITORIES

Provides Relief from
MULTIPLE SYMPTOMS

Reduces Internal Swelling,
Soothes & Protects
Prompt Soothing Relief
from Painful Burning,
Itching and Discomfort
Also for Nighttime Relief

+ 4 FREE
WIPES
INSIDE

12 SUPPOSITORIES

PREPARATION H 
cocoa butter, phenylephrine hydrochloride, and witch hazel kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2884
Packaging
#Item CodePackage Description
1NDC:0573-2884-121 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 APPLICATOR
Part 1 of 2
PREPARATION H 
cocoa butter and phenylephrine hydrochloride suppository
Product Information
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (COCOA BUTTER) COCOA BUTTER2211 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE6.25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
METHYLPARABEN 
PROPYLPARABEN 
Product Characteristics
ColorYELLOW (Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
112 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34607/01/2015
Part 2 of 2
PREPARATION H TOTABLES IRRITATION RELIEF WIPES 
witch hazel cloth
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL5 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ANHYDROUS CITRIC ACID 
CAPRYL/CAPRAMIDOPROPYL BETAINE 
DIAZOLIDINYL UREA 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL, (R)- 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
Product Characteristics
ColorWHITE (white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
14 CLOTH in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34607/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34607/01/2015
Labeler - Pfizer Consumer Healthcare (828831730)

 
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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