Preparation H Kit
FDA Label NDC 0573-2884

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Preparation H (NDC 0573-2884). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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
    Image 1 (Preparation H 01)

    Image 1 (Preparation H 01)


    Image 2 (Preparation H 02)

    Image 2 (Preparation H 02)

  • 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

  • ✓Reduces Internal Swelling,
    Soothes & Protects
  • ✓Prompt Soothing Relief
    from Painful Burning,
    Itching and Discomfort
  • ✓Also for Nighttime Relief
  • + 4 FREE
    WIPES
    INSIDE

    12 SUPPOSITORIES

    Principal Display Panel (Kit Carton)

    Principal Display Panel (Kit Carton)

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