QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER- bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointment

QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER by

Drug Labeling and Warnings

QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Uses

help prevent infection and temporarily relieves pain 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 Poison Control Center right away.

INDICATIONS & USAGE

Directions  

Adults and children 2 years and older:

• clean affected area
• apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily

• may be covered with a sterile bandage   

Children under 2 years: ask a doctor

STORAGE AND HANDLING

Other information

• store at 15o to 25o C (59o to 77o F)
• Lot No. and Exp. Date: see box or crimp of tube
  

INACTIVE INGREDIENT

Inactive ingredients

white petrolatum, Polysorbate 80, Stearic acid polyoxil 40, Methylparaben, Propylparaben, Purified Water

DOSAGE & ADMINISTRATION

Distributed By Quality Choice

NOVI, MI 48376-0995

MADE IN KOREA

QC 94594

www.chaindrug.com

PRINCIPAL DISPLAY PANEL

Enter section text here

ACTIVE INGREDIENT

Active Ingredients (in each gram)                                                                      Purpose

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 hydrochloride 10 mg........................................................................Pain reliever

INGREDIENTS AND APPEARANCE

QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER 
bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-945
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B SULFATE	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
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-945-94	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	02/09/2012

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)