Triple Antibiotic Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate)

Drug Labeling and Warnings

Drug Details [pdf]

TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
L&R Distributors, 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 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.

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SATISFACTION GUARANTEED
NDC: 15127-122-05
Triple Antibiotic Ointment
Bacitracin Zinc – Neomycin Sulfate – Polymyxin B Sulfate
*Compare to the active ingredients in Neosporin®
First Aid Antibiotic
To Help Prevent Infection in Minor Cuts, Scrapes, and Burns 

NET WT 0.5 OZ (14g)

Triple Antibiotic Ointment

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15127-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  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 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 15127-122-051 in 1 CARTON09/23/200502/28/2019
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 15127-122-011 in 1 CARTON09/23/200509/30/2018
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/23/200502/28/2019
Labeler - L&R Distributors, Inc. (012578514)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 7/2019
 
L&R Distributors, Inc.