Leader Hemorrhoidal Suppository
FDA Label NDC 70000-0223

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Hemorrhoidal (NDC 70000-0223). 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 active ingredients (in each suppository), purposes, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Suppository)

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Purposes

Protectant

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. (1-800-222-1222)

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
  • see illustrations: 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

methylparaben, propylparaben, topical starch

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Hemorrhoidal Suppositories

Reduces Internal Swelling

Soothes and Protects

Prompt Soothing Relief From Painful Burning, Itching and Discomfort

For Nighttime Relief

12 SUPPOSITORIES

COMPARE TO PREPARATION H®

active ingredients

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