TRIPLE ANTIBIOTIC- bacitracin, neomycin, polymyxin b ointment
Lake Erie Medical DBA Quality Care Products 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.

----------

Perrigo Triple Antibiotic Ointment Drug Facts

Active ingredient (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 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 1 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 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 20°-25°C (68°-77°F)

Inactive ingredients

light mineral oil, white petrolatum

Questions or comments?

1-800-719-9260

Image of Label

TRIPLE ANTIBIOTIC
bacitracin, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49999-154(NDC:45802-061)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	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
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49999-154-15	1 in 1 CARTON	03/07/2011	01/29/2015
1		14 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:49999-154-30	1 in 1 CARTON	03/07/2011	01/29/2015
2		28 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/07/2011	01/29/2015

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Name	Address	ID/FEI	Business Operations
Establishment
Lake Erie Medical DBA Quality Care Products LLC		831276758	relabel(49999-154)

Revised: 3/2018

Document Id: 38e64917-b28e-4dc0-a7e0-bd38c750547e

Set id: bd0166a6-93d2-4b35-beb9-1a770acf249e

Version: 4002

Effective Time: 20180320

Lake Erie Medical DBA Quality Care Products LLC