Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment
FDA Label NDC 0536-1211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories Inc. for the product Dibucaine Topical Anesthetic 1% Hemorrhoidal (NDC 0536-1211). 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, allergy alert, do not use, when using this product, 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

Hemmorhoidal ointment

​Use

  • temporarily relieves pain and itching due to hemorrhoids and 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 does not subside or if redness, irritaion, swelling, bleeding 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

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 with toilet tissue or a soft cloth before applying.
  • apply externally to the affected area up to 3 to 4 times daily.
  • children under 12 years of age:  ask a doctor

​Other Information

  • Store at 20-25 ​o​C (68-77 ​o​F)
  • tamper-evident:  do not use if foil seal is broken or missing

Other

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Questions Or Comments?

call 1-800-645-2158

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