NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC - neomycin and polymyxin b sulfates and bacitracin zinc ointment 
H.J. Harkins Company, Inc.

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.

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Fougera ® Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

Drug Facts

Active ingredients (in each gram)

 
Neomycin Sulfate (5 mg equivalent to 3.5 mg neomycin base)
 
Polymyxin B Sulfate (equal to 5.000 polymyxin B units)
 
Bacitracin Zinc (equal to 400 bacitracin units)

Purpose

Antibiotic
Antibiotic
Antibiotic

Uses

first aid to help prevent infection in
  • minor cuts
  • scopes
  • bums

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 serous 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 52959-014

Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

Repacked by:

H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA

Label


NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 
neomycin and polymyxin b sulfates and bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-014(NDC:0168-0012)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES) Bacitracin Zinc400 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-014-0514.17 g in 1 TUBE
2NDC:52959-014-0328.34 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)
Registrant - Nycomed US Inc. (043838424)
Establishment
NameAddressID/FEIBusiness Operations
Nycomed US Inc.174491316MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Nycomed US Inc.043838424ANALYSIS, MANUFACTURE

Revised: 8/2011
Document Id: 2501c5c7-df08-4d3a-8ee6-6c28e3c985f9
Set id: dc8dbd0f-fe07-4308-b9a5-a031e8a41e74
Version: 1
Effective Time: 20110830
 
H.J. Harkins Company, Inc.