Nupercainal
FDA Label NDC 55741-402

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Nupercainal (NDC 55741-402). 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, 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

→ Other

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Allergy Alert

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 56.7g Tube Box

Other

Drug Facts

Active Ingredient

Dibucaine 1%

Purpose

Hemorrhoidal ointment

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 symptom being treated does not subside or if redness, irritation, 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 within 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care 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.

Directions

adults and children 12 years and over: if possible, clean the affected area with mild soap and warm water and rinse thoroughly. gently 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