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FDA LABEL GENERIC: Dibucaine MFR: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Dibucaine 0.01 Mg/mg Topical Ointment

Table of Contents

Active Ingredient:
Purpose:
INDICATIONS AND USAGE
WARNINGS
Keep out of reach of children.
DOSAGE AND ADMINISTRATION
Inactive Ingredients

Active Ingredient:

Dibucaine 1%

Purpose:

Topical Anesthetic

INDICATIONS AND USAGE

Uses:

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

WARNINGS

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.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON