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| Product NDC Code | 63187-299 | ||||
|---|---|---|---|---|---|
| Drug Name | Bacitracin |
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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 | 1648110 | ||||
| Application Number | M004 | ||||
| Labeler Name | Proficient Rx LP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Bacitracin 500 Units Antibiotic
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.Dosage and Administration: • clean the affected areas • apply a small amount of product (an amount equal to the surface area of the tip of the 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 Light Mineral Oil, 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.Indications and Usage Ask a doctor before use: • in case of deep or puncture wounds • animal bites • serious burns
Purpose
Information about the drug product’s indications for use.Purpose First aid to help prevent infection in: Minor cuts scrapes burns
Spl product data elements
Usually a list of ingredients in a drug product.Bacitracin Bacitracin MINERAL OIL PETROLATUM BACITRACIN BACITRACIN
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.Principal Display Panel Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320 Bacitracin Ointment: bacitracin-galentic-ointment-01.jpg 63187-299-01
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.Other information • store at controlled room temperature 15°-30° C (59°-86° F)
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: • if you are allergic to any of the ingredients • in the eyes • 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, or if a rash or other allergic reaction develops.
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 Dosage and Administration: • clean the affected areas • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily • may be covered with a sterile bandage Stop use and ask a doctor if • the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use: • if you are allergic to any of the ingredients • in the eyes • over large areas of the body • longer than 1 week unless directed by a doctor 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