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Product NDC Code | 68001-477 | ||||||||
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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 | BluePoint Laboratories | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Bacitracin (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.Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antibiotic
Uses First aid to help prevent infection in minor cuts, scrapes and burns
Spl product data elements
Usually a list of ingredients in a drug product.Bacitracin Bacitracin MINERAL OIL PARAFFIN WHITE 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 Bacitracin sachet and carton 0.9g 0.9 sachet 0.9 carton
Bacitracin tube and carton 14.2g 14g tube 14g carton
Bacitracin 28.4g tube and carton 28g tube 28g carton
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
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 or apply over large areas of body if you are allergic to any of the ingredients 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 Centre right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact- 1-800-707-4621 Manufactured in India by: Gopaldas Visram & Company Limited, Plot No. A327, T.T.C. Indl. Area, M.I.D.C. Mahape, Navi Mumbai - 400710. Mfg. Lic. No.: KD/503 For BluePoint Laboratories Rev 09/2021
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 Do not use in the eyes or apply over large areas of body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor
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