QUALITY CHOICE MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and 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 ingredient (in each gram) Purposes

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

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

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

Pramoxine HCI 10 mg.............................................................External analgesic

PURPOSE

Uses

• first aid to help prevent infection and for the temporary relief of pain in minor:
• cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• if you are allergic to any of the ingredients
• in the eyes or nose
• over large areas of the body

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

STOP USE

Stop use and ask a doctor if

• you need to use longer than 1 week
• rash or other allergic reaction develops
• symptoms persist for more than 1 week, or clear up and occur again within a few days
• condition persists or gets worse
• redness, irritation, swelling, or pain persists or increases

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• adults and children 2 years of age and older:
• clean the affected area
• 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
• children under 2 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

cetyl alcohol, light mineral oil, polyoxyl 40 stearate, stearic acid, white petrolatum

DOSAGE & ADMINISTRATION

Distributed by:

C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PETROLATUM (UNII: 4T6H12BN9U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-009-28	1 in 1 CARTON	12/19/2019
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	12/19/2019

Labeler - Chain Drug Marketing Association Inc (011920774)