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LEADER TRIPLE ANTIBIOTIC by CARDINAL HEALTH

Dosage form: ointment
Ingredients: BACITRACIN 400[iU] in 1g, NEOMYCIN 3.5mg in 1g, POLYMYXIN B SULFATE 5000[iU] in 1g
Labeler: CARDINAL HEALTH
NDC Code: 37205-273

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

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

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.  If swallowed, get medical help or contact a Poison Control Center right away

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

Other information

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

Inactive ingredients

liquid paraffin, white petrolatum, polyoxyl 40 stearate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 1068808

www.myleader.com

1-800-200-6313

Made in Korea

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LEADER TRIPLE ANTIBIOTIC  
bacitracin, neomycin sulfate, polymyxin-b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-273
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (BACITRACIN) BACITRACIN400 [iU]  in 1 g
NEOMYCIN (NEOMYCIN) NEOMYCIN 3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
POLYOXYL 40 STEARATE 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:37205-273-101 TUBE (TUBE) in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/01/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 03/2012
 
CARDINAL HEALTH

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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