Active Ingredient
Bacitracin zinc 500 Units
Neomycin Sulfate 3.5mg
Polymyxin B Sulfate 10,000 Units
Pramoxine HCL 10mg
Leader Triple Antibiotic And Pain Relief Ointment
FDA Label NDC 70000-0625
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110 Dba Leader for the product Leader Triple Antibiotic And Pain Relief (NDC 70000-0625). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use, stop use and ask a doctor if:, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
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
* Please review the disclaimer below.
