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

Triple Antibiotic GRX by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin 400 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 5,000 units	First aid antibiotic

Use

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 15° to 30°C (59° to 86° F)

Inactive ingredients

Mineral oil, petrolatum

Questions?

call 1-800-736-3437

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	400 [iU]  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 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
Petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-080-09	0.9 g in 1 POUCH; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	12/01/2017

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-080)