QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment

Quality Choice Maximum Strength Triple Antibiotic by

Drug Labeling and Warnings

Quality Choice Maximum Strength Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram)                                               Purpose

Bacitracin zinc 500 units......................................................... First aid antibiotic

Neomycin 3.5 mg.................................................................. First aid antibiotic

Polymyxin B sulfate 10,000 units............................................ First aid antibiotic

Pramoxine hydrochloride 10 mg.............................................. First aid analgesic

PURPOSE

Uses

Helps prevent infection and temporarily relieves pains due to:

• minor cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only

Allergy alert: do not use if allergic to any of the ingredients

DO NOT USE

Do not use

• in or near the eyes
• over large areas of the body
• longer than 1 week

ASK DOCTOR

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

STOP USE

Stop use and ask a doctor if:

• condition persists or gets worse
• symptoms last for more than 7 days or clear up and comes back within a few days
• a rash or other allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

Adults and children 2 years of age and older:

• clean the affected area
• apply a small amount equal to surface area of a finger tip, on area 1 to 3 times daily
• may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• Store at 20° to 25°C (68° to 77°F)
• Lot No. & Exp. Date: see box or crimp or tube

INACTIVE INGREDIENT

Inactive ingredients

methylparaben, liquid paraffin, white petrolatum, polyoxyl 40 stearate, proplyparaben

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-910
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
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-910-01	1 in 1 CARTON	10/12/2016
1		28 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	03/25/2014

Labeler - Chain Drug Marketing Association Inc (011920774)