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| Product NDC Code | 53329-089 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | First aid antibiotic |
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| Type | Brand | ||||||||
| 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 | part333B | ||||||||
| Labeler Name | Medline Industries, LP | ||||||||
| 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 (in each gram) Bacitracin Zinc 500 units, USP
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 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.First Aid Antibiotic bacitracin zinc MINERAL OIL WHITE PETROLATUM BACITRACIN ZINC BACITRACIN PARAFFIN
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.Package Label Label V3 RI22GZP
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Warnings and Precautions
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.Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA of domestic and imported materials 1-800-633-5463 REF: CUR110556 V3 RI22GZP
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 on deep or puncture wounds, animal bites, or serious burns
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in the eyes if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock over large areas of the body longer than 1 week unless directed by a doctor
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.
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 the condition persists or gets worse if a rash or other allergic reaction occurs
Storage and handling
Information about safe storage and handling of the drug product.Other information store at controlled room temperature 68º-77ºF (20º-25ºC) tamper evident, do not use if pack is torn, cut or opened avoid excessive heat and humidity
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 if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock over large areas of the body longer than 1 week unless directed by a doctor Ask a doctor before use on deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if the condition persists or gets worse if a rash or other allergic reaction occurs 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