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| Product NDC Code | 0904-6679 | ||||
|---|---|---|---|---|---|
| Drug Name | Major bacitracin zinc |
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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 | Major Pharmaceuticals | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (In each gram) Bacitracin 500
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 (equal to surface area of tip of 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 ingredient 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.Major Bacitracin Zinc Bacitracin Zinc Bacitracin Zinc Bacitracin 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.Principal Display Panel – Carton Label Major NDC 0904-6679-67 Bacitracin Zinc Ointment USP Bacitracin Zinc 500 units 144 Unit dose Packets First Aid Antibiotic Ointment NET WT. 0.9g (0.03oz) Principal Display Panel – Carton Label
Principal Display Panel – Packet Label Major NDC 0904-6679-67 Bacitracin Zinc Ointment Bacitracin Zinc 500 Units 144 Unit Dose Packets First Aid Antibiotic Ointment Protection against Infection NET WT. 0.9g (0.03oz) Principal Display Panel – Packet Label
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
Other information Store at a controlled room temperature 20º-25ºC (68° to 77°F)
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.Consult a doctor before use if you have deep or puncture wounds animal bites 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 or near the eyes on large areas of the body
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 the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-616-2471
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 consult a doctor if condition persists or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction develops
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use longer than 1 week
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 Allergy alert: do not use if you are allergic to any of the ingredients Do not use in or near the eyes on large areas of the body Consult a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use longer than 1 week Stop use and consult a doctor if condition persists or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction develops Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
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