Dibucaine
FDA Label NDC 54162-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Dibucaine (NDC 54162-011). 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

Aceton Sodium Bisulfate, Lanolin, Mineral Oil, Purified water, White Petrolatum

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

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