LEADER TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment

LEADER TRIPLE ANTIBIOTIC PLUS by

Drug Labeling and Warnings

LEADER TRIPLE ANTIBIOTIC PLUS by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. 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 Sulfate 3.5 mg.................................................................................First aid antibiotic

Polymyxin-B Sulfate 10,000 units.....................................................................First aid antibiotic

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

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

WHEN USING

When using this product do not use longer than 1 week

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   

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

white petrolatum, water

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 2372167

www.myleader.com

1-800-200-6313

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER TRIPLE ANTIBIOTIC PLUS 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-266
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
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-266-10	1 in 1 CARTON	03/01/2012
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	03/01/2012

Labeler - CARDINAL HEALTH (097537435)