Triple Antibiotic Ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by H2-Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment 
H2-Pharma, LLC

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 (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.

Do not use

  • if you are allergic to any of the ingredients
  • 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

Stop use and ask a doctor if

  • you need to use longer than one week
  • condition persists or gets worse
  • rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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

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

Inactive ingredient

white petrolatum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC: 61269-179-56
*Compare to the active ingredients in
Neosporin® Original Ointment

Triple Antibiotic Ointment

Bacitracin zinc | Neomycin sulfate | Polymyxin B sulfate Ointment
First aid antibiotic

For external use only
First aid antibiotic to help prevent infection in minor cuts, scrapes, and burns

Net wt. 1 oz (28 g)

H2 pharma

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61269-179
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Product Characteristics
ColorYELLOW (light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61269-179-561 in 1 CARTON05/24/202105/31/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 61269-179-341 in 1 CARTON05/24/202108/31/2023
214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B05/24/202108/31/2023
Labeler - H2-Pharma, LLC (028473634)

Revised: 2/2023
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.