Bacitracin Zinc and Polymyxin B Sulfate

Dosage form: ointment
Ingredients: Bacitracin Zinc 500[USP'U] in 1g, Polymyxin B Sulfate 1000[USP'U] in 1g
Labeler: H.J. Harkins Company, Inc.
NDC Code: 52959-054

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.

Fougera ® Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

Antibiotic

Antibiotic

Uses first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burn

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Ask a doctor before use in case of deep or puncture wounds, animal bites or serious bums

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if a rash or other allergic reaction develops

Keep out of reach of children.

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

Directions

  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Other information

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature
  • see crimp of tube for Lot No. and Exp. date

Inactive ingredient white petrolatum

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

Fougera®

NDC 0168-0021-35

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444

BACITRACIN ZINC AND POLYMYXIN B SULFATE 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-054(NDC:0168-0021)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin) Bacitracin Zinc500 [USP'U]  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate1000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:52959-054-0314.17 g in 1 TUBE
2NDC:52959-054-0728.34 g in 1 TUBE
3NDC:52959-054-44144 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/06/2010
Labeler - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIOperations
Nycomed US Inc.174491316MANUFACTURE
Establishment
NameAddressID/FEIOperations
Nycomed US Inc.043838424ANALYSIS, MANUFACTURE

Revised: 08/2011
 
H.J. Harkins Company, Inc.

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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