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 Chain Drug Marketing Association, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (each gram contains)

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

Purpose

First Aid Antibiotic Ointment

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

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

Ask Doctor before use if you have

• Deep or puncture wounds
• Animal bites
• Serious burns

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.

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.

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 crimp for lot number and expiration date.

INACTIVE INGREDIENT

Inactive ingredientMineral Oil, Petrolatum

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc. ©
43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information:

This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered trademark Neosporin®

Packaging

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-459
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: 63868-459-10	1 in 1 BOX	05/24/2019
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63868-459-05	1 in 1 BOX	03/26/2019
2		14.2 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	03/26/2019

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Trifecta Pharmaceuticals USA (079424163)