Dibucaine Ointment
FDA Label NDC 71399-2829

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Dibucaine (NDC 71399-2829). 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, uses, directions, warninigs, inactive ingredients, otc - keep out of reach of children, storage and handling, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient                        Purpose

Dibucaine 1%                  Topical Anesthetic

Uses

For temporary relief of pain and itching associated with sunburn, minor burns, hemorrhoids, cuts, scratches, insect bites, stings

Directions

Not for prolonged use

Adults should not use more than 1oz in 24 hours or 1/4 oz for child

Apply to affected area 3 or 4 times daily

Cover with light dressing, if necessary

Warninigs

For External Use Only

Do not get into the eyes. Stop use and ask a doctor if the condition persists of if rash and irritation develops. you have rectal bleeding

Inactive Ingredients

Sodium Metabisulfite, Lanolin,White Petrolatum

NDC: 71399-2829-1

Size: 28 G

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

In the event of accidental ingestion, contact a Poison Control Center right away

Storage And Handling

Store at room temperature 15-30'C (59-86'F)

Dosage & Administration

Apply to affected area 3 or 4 times daily

Questions Or Comments?

Call (877) 225-6999 Monday - Friday 9AM-5PM EST

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

Manufactured In USA

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