PREMIER VALUE TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Premier Value Triple Antibiotic by

Drug Labeling and Warnings

Premier Value Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Premier Value Alliance LLC., Trifecta Pharmaceuticals USA LLC.. 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

INACTIVE INGREDIENT

Inactive ingredient:Mineral Oil and 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 1-866-923-4914

Other Information

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087

Product of PRC

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIER VALUE TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-320
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-320-05	1 in 1 BOX	01/10/2019
1		14 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	01/10/2019

Labeler - Premier Value Alliance LLC. (101668460)

Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)