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Triple antibiotic - Medication Information

Product NDC Code 67510-0170
Drug Name

Triple antibiotic

Type Brand
Pharm Class Aminoglycoside Antibacterial [EPC],
Aminoglycosides [CS],
Decreased Cell Wall Synthesis & Repair [PE],
Polymyxin-class Antibacterial [EPC],
Polymyxins [CS]
Active Ingredients
Bacitracin zinc 400 [usp'u]/g
Neomycin sulfate 3.5 mg/g
Polymyxin b sulfate 5000 [usp'u]/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 204602
Application Number part333B
Labeler Name Kareway Product, Inc.
Packages
Package NDC Code Description
67510-0170-1 1 tube in 1 box (67510-0170-1) / 28 g in 1 tube
67510-0170-3 1 tube in 1 box (67510-0170-3) / 9.4 g in 1 tube
67510-0170-5 1 tube in 1 box (67510-0170-5) / 14 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg 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 adults and children 2 years of age or older: clean the affected area apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, 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 First aid antibiotic First aid antibiotic

Spl product data elements

Usually a list of ingredients in a drug product.
Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B CETYL ALCOHOL GLYCERIN LIGHT MINERAL OIL STEARETH-2 SQUALANE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- PETROLATUM 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.
Package label panel Triple Antibiotic Ointment image of a 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 serious burns deep or puncture wounds animal bites

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.

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 you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. 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.
When using this product do not use in the eyes do not apply over large areas of the body

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 59° to 77°F

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 if you are allergic to any of the ingredients Ask a doctor before use if you have serious burns deep or puncture wounds animal bites When using this product do not use in the eyes do not apply over large areas of the body Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. 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