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| Product NDC Code | 69396-002 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | TRIFECTA PHARMACEUTICALS USA LLC | ||||||||||||||||||
| 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 (each gram contains) Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units
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 and dry thoroughly. ● 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 ingredient light Mineral Oil, 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.Purpose First aid antibiotic
Spl product data elements
Usually a list of ingredients in a drug product.Triple Antibiotic Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate. PETROLATUM LIGHT MINERAL OIL BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN 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.Packaging image description
400603-FBA GLOBE TRIPLE ANTIBIOTIC OINTMENT 1OZ 3PK_BOX 022824 CDER
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.Other information ● To open: unscrew cap, pull tab to remove foil seal ● store at 20° to 25°C ( 68° to 77°F) ● see carton or tube for lot number and expiration date.
Distributed by: Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301, USA 1-888-296-9067
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? Call 1-888-296-9067
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 ● if you are allergic to any of the ingredients. Ask a doctor before use if you have ● deep or puncture wounds ● animal bites ● serious burns. Stop use and ask a doctor if ● condition persists or gets worse ● you need to use longer than 1 week ● 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