LEADER FIRST AID ANTIBIOTIC- bacitracin zinc, and polymyxin b sulfate ointment 
Cardinal Health

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.

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Active ingredients (in each gram)                                     Purpose

Bacitracin 500 units...........................................................First aid antibiotic

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

Uses

first aid to help prevent infection in minor:

Warnings

For external use only.

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

white petrolatum base

Distributed by:

Cardinal Health

Dublin, Ohion 43017

www.myleader.com

1-800-200-6313

Made in Korea

image description

LEADER FIRST AID ANTIBIOTIC 
bacitracin zinc, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0111-11 in 1 CARTON
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/09/2016
Labeler - Cardinal Health (097537435)

Revised: 3/2016
Document Id: 7dd7f6f3-4d4b-4418-9485-2b3672b8b53b
Set id: c148e675-bc5d-415c-b5ba-dfca6637f93f
Version: 1
Effective Time: 20160318
 
Cardinal Health