TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Triple Antibiotic Plus Pain Relief by

Drug Labeling and Warnings

Triple Antibiotic Plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc., 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

Active Ingredient

Pramoxine HCL

Purpose

External Analgesic

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 ingredientMineral Oil,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 crimp for lot number and expiration date.

Other Information

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

questions: 800-935-2362

Product of PRC

Packaging

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-576
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [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	10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  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: 63868-576-01	1 in 1 BOX	06/15/2020
1		28.3 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	06/15/2020

Labeler - Chain Drug Marketing Association Inc. (011920774)

Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)