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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Version: 3

Effective Time: 20230207

H2-Pharma, LLC