LEADER TRIPLE ANTIBIOTIC PLUS

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[USP'U] in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 10000[USP'U] in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: CARDINAL HEALTH
NDC Code: 37205-266

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 (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

Uses

help prevent infection and temporarily relieves pain due to

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy alert: do not use if allergic to any of the ingredients

Do not use

  • in or near the eyes
  • over large areas of the body
  • longer than 1 week

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

When using this product do not use longer than 1 week

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

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   

Other information

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

Inactive ingredients

white petrolatum, water

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 2372167

www.myleader.com

1-800-200-6313

Made in Korea

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LEADER TRIPLE ANTIBIOTIC PLUS 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-266
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC500 [USP'U]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:37205-266-101 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

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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