LEADER TRIPLE ANTIBIOTIC- bacitracin, neomycin sulfate, polymyxin-b sulfate ointment

LEADER TRIPLE ANTIBIOTIC by

Drug Labeling and Warnings

LEADER TRIPLE ANTIBIOTIC 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 (each gram contains)                                                                   Purpose

Bacitracin 400 units ...............................................................................................First Aid Antibiotic

Neomycin Sulfate equivalent to 3.5mg of Neomycin Base ........................................First Aid Antibiotic

Polymyxin-B Sulfate 5000 units ..............................................................................First Aid Antibiotic

PURPOSE

Uses

first aid to help prevent infection in

• minor cuts
• scrapes
• burns
  

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• in the eyes
• if you are allergic to any of the ingredients
• over large areas of the body
• longer than 1 week unless directed by a doctor
  

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

• the condition persists or gets worse
• a rash or other allergic reaction develops
  

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

• 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
  

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 1068808

www.myleader.com

1-800-200-6313

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER TRIPLE ANTIBIOTIC 
bacitracin, neomycin sulfate, polymyxin-b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-273
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  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	5000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-273-10	1 in 1 CARTON	01/01/2015
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)