FDA Label for Preparation H

View Indications, Usage & Precautions

Preparation H Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Preparation H® Suppositories

Drug Facts

Preparation H® Totables® Irritation Relief Wipes

Drug Facts


Otc - Purpose



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

Warnings



For rectal use only

For external use only


Otc - Ask Doctor



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.


Otc - When Using



When using this product do not exceed the recommended daily dosage unless directed by a doctor

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

Otc - Stop Use



Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days

Otc - Pregnancy Or Breast Feeding



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

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.

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
    • 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)

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

Inactive Ingredients



corn starch, methylparaben, propylparaben

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

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.


Active Ingredient



Witch hazel 50.0%


Purpose



Astringent


Principal Display Panel - Kit Carton



SAME AMOUNT
Smaller Package

PREPARATION H®
HEMORRHOIDAL
SUPPOSITORIES

Provides Relief from
MULTIPLE SYMPTOMS

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