TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Chain Drug Marketing Association 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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Triple Antibiotic Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate)

Drug Facts

Active Ingredients (in each gram)

Bacitracin zinc, USP 400 units
Neomycin sulfate, USP 3.5 mg
Polymyxin B sulfate, USP 5,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients

Do not use

  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns 

When using this product

  • do not use longer than 1 week unless directed by a doctor 

Stop use and ask a doctor if

  • condition persists or gets worse
  • 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 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

  • Store at controlled room temperature 59°-86°F (15°-30°C).
  • Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

NDC 63868-359-28
QC QUALITY CHOICE®
*Compare to the active ingredients in NEOSPORIN®

Triple Antibiotic Ointment
Bacitracin Zinc | Neomycin Sulfate | Polymyxin B Sulfate
First Aid Antibiotic
Helps Prevent Infection in
Minor Cuts | Scrapes | Burns

1 OZ NET WT (28 g)

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TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-359
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-359-2828 g in 1 TUBE; Type 0: Not a Combination Product08/29/200712/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B08/29/200712/31/2016
Labeler - Chain Drug Marketing Association Inc. (011920774)

Revised: 12/2017
Document Id: 681facb8-d5a7-4bee-bcf1-37fb49b2b091
Set id: b13a2b74-66ee-44ec-bf9a-42b10a40525e
Version: 3
Effective Time: 20171222
 
Chain Drug Marketing Association Inc.