LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF- bacitracin,neomycin,polymxin, pramoxine ointment

Leader Triple antibiotic and pain relief by

Drug Labeling and Warnings

Leader Triple antibiotic and pain relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110 dba LEADER, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Cuts
• Scrapes
• Burns

Warnings

For external use only. Do not use:

• In eyes
• Over large areas of the body
• If you are allergic to any of the ingredients

Ask a Doctor before Use

Ask Doctor before use if you have:

• Deep or puncture wouns
• Animal bites
• Serious burns

Stop Use and ask a Doctor if:

• Symptoms persists for more than 1 week or clear up and occur again within a few days.
• Condition persists or gets worse
• You need to use longer than 1 week
• A rash or other allergic reaction develops

Keep out of Reach of Children

If Swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• Clean the affected area and dry thoroughly
• 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
• Children under 2 years of age: ask doctor

Other Information

• To Open: Unscrew cap, tear foil safety seal off.
• Store at 20° to 25°C (68° to 77°F)
• See carton or tube crimp for lot number and expiration date

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

INGREDIENTS AND APPEARANCE

LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0625
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0625-1	1 in 1 BOX	02/15/2023
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	02/15/2023

Labeler - Cardinal Health 110 dba LEADER (063997360)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)