DIBUCAINE by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DIBUCAINE ointment

DIBUCAINE by

Drug Labeling and Warnings

DIBUCAINE by is a Otc medication manufactured, distributed, or labeled by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Dibucaine 1%

Purpose:

Topical Anesthetic

INDICATIONS & 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 & 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

NDC: 0168-0046-31

Fougera®

DIBUCAINE OINTMENT USP, 1%

TOPICAL ANESTHETIC

NET WT 28.35g (1 Oz)

Laminate Tube with Child-Resistant Cap

FOR EXTERNAL USE ONLY

DO NOT USE IN THE EYES

INGREDIENTS AND APPEARANCE

DIBUCAINE 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACETONE SODIUM BISULFITE (UNII: 47VY054OXY)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0046-31	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/01/1968

Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)