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| Product NDC Code | 79503-107 | ||||
|---|---|---|---|---|---|
| Drug Name | Bacitracin zinc |
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| Type | Generic | ||||
| Pharm Class | Decreased Cell Wall Synthesis & Repair [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1366116 | ||||
| Application Number | M004 | ||||
| Labeler Name | Ezricare Llc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Bacitracin Zinc (500 units in each gram)
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. 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Mineral Oil, Paraffin, White 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 in minor cuts, scrapes, and burns
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antibiotic
Spl product data elements
Usually a list of ingredients in a drug product.Bacitracin Zinc Bacitracin Zinc BACITRACIN ZINC BACITRACIN MINERAL OIL PARAFFIN WHITE PETROLATUM
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 Ezricare-107
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
Helps Prevent Infection In Minor Cuts, Scrapes & Burns First Aid to Help Prevent Infection in Minor Cuts, Scrapes & Burns Distributed by: EzriCare, LLC Lakewood, NJ www.EzriCare.com Made in India
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 right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 718-502-6610 between 9 am to 4 pm EST, Monday-Friday.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiry 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 the eyes or apply over large areas of the body • if you are allergic to any of the ingredients • longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if the condition persists or get worse, or if a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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