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

Medically reviewed on July 25, 2017

Dosage form: ointment
Ingredients: DIBUCAINE 1g in 100g
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0046

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DIBUCAINE OINTMENT USP, 1%

Active Ingredient:

Dibucaine 1%

Purpose:

Topical Anesthetic

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

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

DIBUCAINE 
dibucaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0046
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIBUCAINE (DIBUCAINE) DIBUCAINE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACETONE SODIUM BISULFITE 
LANOLIN 
PETROLATUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:0168-0046-311 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/1968
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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