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| Product NDC Code | 58980-012 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Bacitracin zinc |
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| Type | Brand | ||||||
| Pharm Class | 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 | 308512 | ||||||
| Application Number | part333B | ||||||
| Labeler Name | STRATUS PHARMACEUTICALS INC | ||||||
| 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) Purpose Bacitracin zinc 500 units First aid antibiotic Polymyxin B 10,000 units First aid antibiotic
| Bacitracin zinc 500 units | First aid antibiotic |
| Polymyxin B 10,000 units | First aid 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.Directions Clean the affected area Apply a small amount of this product on the area 1 to 3 times May be covered with a sterile bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient 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.Active ingredient (in each gram) Purpose Bacitracin zinc 500 units First aid antibiotic Polymyxin B 10,000 units First aid antibiotic
| Bacitracin zinc 500 units | First aid antibiotic |
| Polymyxin B 10,000 units | First aid antibiotic |
Spl product data elements
Usually a list of ingredients in a drug product.BACITRACIN ZINC BACITRACIN ZINC and POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM OFF WHITE
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 - 0.9 g Packet Box NDC 58980-012-01 STRATUSCARE Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP) First Aid Antibiotic Distributed by: STRATUS PHARMACEUTICALS INC 1 GROSS Net Wt. 0.9g (1/32 oz) PACKETTES Principal Display Panel - 0.9 g Packet Box
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: Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186
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 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 the eyes over 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 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? Call toll-free 1-800-442-7882
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 condition persists or gets worse 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 then one week unless directed by doctor
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature Before using any medication, read all label directions.
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 over large areas of the body Allergy alert do not use if allergic to any of the ingredients When using this product do not use longer then one week unless directed by doctor Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if condition persists or gets worse a rash or other allergic reaction develops
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