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.

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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

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61269-179
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color	YELLOW (light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61269-179-56	1 in 1 CARTON	05/24/2021	05/31/2023
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 61269-179-34	1 in 1 CARTON	05/24/2021	08/31/2023
2		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	05/24/2021	08/31/2023

Labeler - H2-Pharma, LLC (028473634)

Revised: 2/2023

Document Id: 1fd0a2b4-b802-4971-89c8-1097ac7b3226

34390-5

Set id: a68f5b34-591d-4a91-9f73-0bb5a37f2c5f

Version: 3

Effective Time: 20230207