DIBUCAINE

E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.

DIBUCAINE OINTMENT USP, 1%

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient:
• Purpose:
• Keep out of reach of children.
• Inactive Ingredients
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

FULL PRESCRIBING INFORMATION

Active Ingredient:

Dibucaine 1%

Purpose:

Topical Anesthetic

Uses

Uses:

• for temporary relief of pain and itching associated with:
• sunburn
• minor burns
• hemorrhoids
• cuts
• scratches
• insect bites
• stings

Warnings:

For external use only

Do not use in the eyes

Stop use and ask a doctor if

• the condition persists or if rash or irritation develops
• you have rectal bleeding

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• not for prolonged use
• adults should not use more than the tube in 24 hours or 1/4 tube for child
• apply to affected area 3 or 4 times daily
• cover with light dressing, if necessary

Other information:

• store at room temperature.
• see crimp of tube for Lot Number and Expiration Date.

Inactive Ingredients

acetone sodium bisulfite 1/2% as a preservative, lanolin, purified water, white petrolatum

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

C4905B

R12/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera^®

NDC 0168-0046-31

CHILD-RESISTANT PACKAGE

DIBUCAINE OINTMENT USP, 1%

TOPICAL ANESTHETIC

NET WT 28.35g (1 Oz)

FOR EXTERNAL USE ONLY

DO NOT USE IN THE EYES