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Product NDC Code | 70000-0625 | ||||||||
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Drug Name | Leader triple antibiotic and pain relief |
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Type | Brand | ||||||||
Pharm Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | OINTMENT | ||||||||
RxCUI drug identifier | 1359350 | ||||||||
Application Number | M004 | ||||||||
Labeler Name | Cardinal Health 110 dba LEADER | ||||||||
Packages |
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Check if available Online | Get Medication Prices online with Discount |
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