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Leader triple antibiotic and pain relief - Medication Information

Product NDC Code 70000-0625
Drug Name

Leader triple antibiotic and pain relief

Type Brand
Pharm Class Aminoglycoside Antibacterial [EPC],
Aminoglycosides [CS],
Decreased Cell Wall Synthesis & Repair [PE],
Polymyxin-class Antibacterial [EPC],
Polymyxins [CS]
Active Ingredients
Bacitracin zinc 500 [usp'u]/g
Neomycin sulfate 3.5 mg/g
Polymyxin b sulfate 10000 [usp'u]/g
Pramoxine hydrochloride 10 mg/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 1359350
Application Number M004
Labeler Name Cardinal Health 110 dba LEADER
Packages
Package NDC Code Description
70000-0625-1 1 tube in 1 box (70000-0625-1) / 28.4 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Bacitracin zinc 500 Units Active Ingredient Neomycin Sulfate 3.5mg Active Ingredient Polymyxin B Sulfate 10,000 Units Active Ingredient Pramoxine HCL 10mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient: Light mineral oil, Petrolatum

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses First Aid to help prevent infection and for temporary relief of pain or discomfort in minor Cuts Scrapes Burns

Purpose

Information about the drug product’s indications for use.
Purpose First Aid Antibiotic Purpose First Aid Antibiotic Purpose First Aid Antibiotic Purpose External Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Leader Triple antibiotic and pain relief Bacitracin,Neomycin,Polymxin, Pramoxine PETROLATUM LIGHT MINERAL OIL BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN PRAMOXINE HYDROCHLORIDE PRAMOXINE POLYMYXIN B SULFATE POLYMYXIN B

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Packaging Leader Triple Antibiotic + Pain Relief 1oz CDER

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
DRUG FACTS 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

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a Doctor before Use Ask Doctor before use if you have: Deep or puncture wouns Animal bites Serious burns

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of Reach of Children If Swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 1-888-296-9067

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

Storage and handling

Information about safe storage and handling of the drug product.
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

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API