LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF- bacitracin,neomycin,polymxin, pramoxine ointment 
Cardinal Health 110 dba LEADER

----------

Leader Triple Antibiotic Ointment + Pain Relief

DRUG FACTS

Active Ingredient

Bacitracin zinc 500 Units

Purpose

First Aid Antibiotic

Active Ingredient

Neomycin Sulfate 3.5mg

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B Sulfate 10,000 Units

Purpose

First Aid Antibiotic

Active Ingredient

Pramoxine HCL 10mg

Purpose

External Analgesic

Uses

First Aid to help prevent infection and for temporary relief of pain or discomfort in minor

Warnings

For external use only. Do not use:

Ask a Doctor before Use

Ask 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 (1-800-222-1222) immediately.

Directions

Other Information

Inactive Ingredient:

Light mineral oil, Petrolatum

Questions?

Call 1-888-296-9067

Distributed By:

Distributed By:
Cardinal Health

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to care since 1979

This product is not manufactured or distributed by Johnson & Johnson a registered trademark of Neosporin Plus Pain Relief

Packaging

Leader Triple Antibiotic + Pain Relief 1oz CDER

LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0625
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  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)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0625-11 in 1 BOX02/15/2023
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00402/15/2023
Labeler - Cardinal Health 110 dba LEADER (063997360)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2024
Document Id: 0e9d17d0-8094-85ff-e063-6394a90a40a1
Set id: f4c521d9-dd05-1c23-e053-2995a90a6e2c
Version: 4
Effective Time: 20240110
 
Cardinal Health 110 dba LEADER