LEADER Triple Antibiotic Ointment Stick

LEADER Triple Antibiotic Ointment Stick

Drug Labeling and Warnings

Drug Details

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LEADER TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate stick 
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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LEADER Triple Antibiotic Ointment Stick

LEADER Triple Antibiotic Ointment Stick

Drug Facts

Active ingredient (in each gram)

Bacitracin USP 400 units

Neomycin Sulfate USP 3.5 mg

Polymyxin B (Sulfate) 5,000 units

Purpose

First aid antibiotic

Uses:

first aid to help prevent infection and for temporary relief of pain or discomfort in minor

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persist or gets worse
  • rash or other allergic reaction develops

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

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 affected area 1-3 times daily
  • may be covered with a sterile bandage

Other information

  • Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive ingredient:

Bees Wax, Cocoa Butter, Cottonseed Oil, Mineral Oil, Petrolatum Snow White USP, Vitamin E

LEADER Triple Antibiotic Ointment Stick .15oz/4.25g (49781-073-69)

Label
LEADER TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49781-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCOA BUTTER (UNII: 512OYT1CRR)  
COTTONSEED OIL (UNII: H3E878020N)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49781-073-694.5 g in 1 TUBE; Type 0: Not a Combination Product03/20/201406/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/20/201406/01/2016
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(49781-073)

Revised: 12/2018
 
Cardinal Health


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