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Product NDC Code | 68001-531 | ||||||
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Drug Name | 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 | 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 Zinc (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.Uses First aid to help prevent infection in minor cuts, scrapes, and 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.Bacitracin Zinc First Aid Antibiotic MINERAL OIL PARAFFIN BACITRACIN ZINC BACITRACIN WHITE 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.0.5oz Label 0.5 oz label
0.5oz Carton 0.5oz Carton
1oz Label 1oz Label
1oz Carton 1oz Carton
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, 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 or apply over large areas of the 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 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? 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 02/2022
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 develops
Storage and handling
Information about safe storage and handling of the drug product.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 Avoid excessive heat and humidity Preserve in well-closed container See crimp of tube or carton for Lot Number and Expiry Date
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 the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a doctor Ask a doctor before use if you have 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 develops 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