Triple Antibiotic Ointment

Generic Name: bacitracin zinc, neomycin sulfate, and polymyxin b sulfate
Dosage Form: ointment

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.

Triple Antibiotic
Ointment

Drug Facts

Active ingredients
(each gram contains)
Purpose
Bacitracin zinc 400 units First aid antibiotic
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 5,000 units First aid antibiotic

Uses

first aid to help prevent infection in minor:

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  • cuts
  • scrapes
  • burns

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 if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition persists or gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • 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

  • To open: unscrew cap, pull tab to remove foil seal.
  • store at 20°-25°C (68°-77°F)
  • See carton or tube crimp for lot number and expiration date.

Inactive ingredient

white petrolatum

Questions?

Call 1-877-745-6888

Distributed by:
Phoenix Global Supply Group, Inc.
White Plains, NY 10604

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Triple Antibiotic
Ointment
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate

First Aid Antibiotic Ointment

Original Strength

NET WT 1 oz (28.4 g)

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52426-020
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bacitracin zinc (Bacitracin zinc) Bacitracin zinc 400 [iU]  in 1 g
Neomycin sulfate (Neomycin) Neomycin sulfate 3.5 mg  in 1 g
Polymyxin B sulfate (Polymyxin B) Polymyxin B sulfate 5000 [iU]  in 1 g
Inactive Ingredients
Ingredient Name Strength
petrolatum  
Packaging
# Item Code Package Description
1 NDC:52426-020-06 1 TUBE (TUBE) in 1 CARTON
1 28.4 g in 1 TUBE
2 NDC:52426-020-05 1 TUBE (TUBE) in 1 CARTON
2 14.2 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333B 09/23/2010
Labeler - Phoenix Global Supply Group, Inc (843189908)
Establishment
Name Address ID/FEI Operations
SGS Life Science Services 093840643 ANALYSIS
Establishment
Name Address ID/FEI Operations
Axellia Pharmaceuticals ApS 305814345 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Pharmacia and UpJohn Company 829076566 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Axellia Pharmaceuticals AS 561816174 MANUFACTURE
Revised: 09/2010
 
Phoenix Global Supply Group, Inc



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