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Product NDC Code | 73598-1004 | ||||||
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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 | JHK Inc dba American Safety & First Aid | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Bacitracin zinc 400 units first aid antibiotic Neomycin sulfate 3.5 mg first aid antibiotic Polymyxin-B sulfate 5,000 units first aid antibiotic
Bacitracin zinc 400 units | first aid antibiotic |
Neomycin sulfate 3.5 mg | first aid antibiotic |
Polymyxin-B sulfate 5,000 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 May be covered with a sterile bandage Apply a small amount (an amount equal to the surface area of the tip of a finger) one to three times daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient mineral oil, petrolatum, water
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.Use First aid to help prevent infection in minor cuts, scrapes and burns
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Bacitracin zinc 400 units first aid antibiotic Neomycin sulfate 3.5 mg first aid antibiotic Polymyxin-B sulfate 5,000 units first aid antibiotic
Bacitracin zinc 400 units | first aid antibiotic |
Neomycin sulfate 3.5 mg | first aid antibiotic |
Polymyxin-B sulfate 5,000 units | first aid antibiotic |
Spl product data elements
Usually a list of ingredients in a drug product.TRIPLE ANTIBIOTIC BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B MINERAL OIL PETROLATUM WATER
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 - 25 Packet Box Product #1004 Triple Antibiotic Bacitracin-Neomycin-Polymyxin B FIRST AID ANTIBIOTIC 25 - Unit Dose Packets 1/55oz (0.5g) per pouch PRINCIPAL DISPLAY PANEL - 25 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
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 due to the possibility of anaphylactic shock Longer than one 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? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
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 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 packet is torn, cut or opened Store at room temperature; 59 - 86°F (15 - 30°C) See packet for Lot Number and expiration 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 due to the possibility of anaphylactic shock Longer than one week unless directed by a doctor Stop use and ask a doctor if Condition persists or gets worse 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