PS-2261 TRIPLE ANTIBIOTIC, 0.5G ointment

PS-2261 Triple Antibiotic, 0.5g by

Drug Labeling and Warnings

PS-2261 Triple Antibiotic, 0.5g by is a Otc medication manufactured, distributed, or labeled by ProStat First Aid LLC, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Bacitracin Zinc 400 units

Purpose

First Aid Antibiotic

Active Ingredient

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B Sulfate 5000 units

Purpose

First Aid Antibiotic

Use(s)

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For External Use Only

Do not use

In the eyes or apply over large areas of the body

If you are allergic to any of the ingredients

Longer than 1 week unless directed by a doctor

Ask a doctor before use if

You have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

The condition persists or gets worse

A rash or other allergic reation 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 room temperature between 15º-30ºC (59º-86ºF)

Tamper evident. Do not use if packet is torn, cut, or opened

Inactive Ingredient

White Petrolatum

Questions

1-888-900-2920 Monday - Friday 8AM - 4PM PST.

Label

PS-2261 Triple Antibiotic, 0.5g

INGREDIENTS AND APPEARANCE

PS-2261 TRIPLE ANTIBIOTIC, 0.5G 
ps-2261 triple antibiotic, 0.5g ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-2261
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5 mg  in 1 g

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

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-2261-1	1000 in 1 CARTON	07/31/2023
1		10 in 1 BOX
1		0.5 g in 1 PACKET; 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	07/31/2023

Labeler - ProStat First Aid LLC (061263699)

Registrant - Dynarex Corporation (008124539)