Hemorrhoidal Ointment
FDA Label NDC 51316-228

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Hemorrhoidal (NDC 51316-228). 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, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist, 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

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

Purpose

Protectant

Vasoconstrictor

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoid tissue and relieves burning
  • 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

Stop Use And Ask A Doctor If

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into the rectum causes additional pain

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 applying ointment.
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • Children under 12 years of age: ask a doctor.

Other Information

store at room temperature 68° - 77° F (20° - 25° C)

Inactive Ingredients

beeswax, benzoic acid, cetyl alcohol, glycerol, methylparaben, polyoxyethylene lauryl ether, propylparaben, stearyl alcohol

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

* Please review the disclaimer below.