Cvs Topical Analgesic Hemorrhoidal Ointment
FDA Label NDC 51316-207

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 Cvs Topical Analgesic Hemorrhoidal (NDC 51316-207). 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 drug facts, active ingredient, purpose, use, warnings, do not use, 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

Drug Facts

Active Ingredient

Dibucaine 1%

Purpose

Local Anesthetic

Use

  • temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders

Warnings

For external use only.

Allergy alert • certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and ask a doctor.

Do Not Use

  • in or near the eyes
  • in children under 2 years of age

When Using This Product

  • do not use more than directed 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 care professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions

  • adults and children 12 years and over: if possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before applying.
  • apply externally to the affected area up to 3 or 4 times daily.
  • children under 12 years of age: ask a doctor.

Other Information

  • store at room temperature 68° - 77° F (20° - 25° C).
  • tamper-evident: do not use if foil seal is broken or missing

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

* Please review the disclaimer below.