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| Product NDC Code | 68001-483 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Triple antibiotic |
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| Type | Brand | ||||||
| Pharm Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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 | 204602 | ||||||
| Application Number | M004 | ||||||
| Labeler Name | BluePoint Laboratories | ||||||
| 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 ingredients Bacitracin Zinc (400 units in each gram) Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram) Polymyxin B Sulfate (5000 units per 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 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 Antibiotics
Spl product data elements
Usually a list of ingredients in a drug product.Triple Antibiotic First Aid Antibiotic WHITE PETROLATUM NEOMYCIN SULFATE NEOMYCIN BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B
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.Package Label - Principal Display Panel Triple Antibiotic Ointment 0.5 oz NDC: 68001-483-46 tube 0.5 0.5 carton Triple Antibiotic Ointment 1 oz 68001-483-45 1 oz tube 1oz carton
Triple Antibiotic Ointment 1 oz 68001-483-45 1 oz tube 1oz 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 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.L.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
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.Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns
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 temperatue Preserve in well-closed containers 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.
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