TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by TRIFECTA PHARMACEUTICALS USA LLC, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (each gram contains)

Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg 
Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

WARNINGS

Warnings    For external use only.

Do not use ● in the eyes                             ● over large areas of the body

                   ● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds                     ● animal bites                        ● serious burns.

Stop use and ask a doctor if ● condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops 

Directions

 ● clean the affected area and dry thoroughly.

 ● 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.

INACTIVE INGREDIENT

Inactive ingredient light Mineral Oil, White Petrolatum

Other information

● To open: unscrew cap, pull tab to remove foil seal
● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube for lot number and expiration date.

QUESTIONS

Questions?  Call 1-888-296-9067

SPL UNCLASSIFIED SECTION

Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067

Packaging

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (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

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-002-20	1 in 1 BOX	03/13/2017
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-002-05	1 in 1 BOX	08/23/2016
2		15 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	03/10/2015

Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)