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Product NDC Code | 63187-039 | ||||||
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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 | part333B | ||||||
Labeler Name | Proficient Rx LP | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS (in each gram) Bacitracin zinc, USP 400 units Neomycin sulfate, USP 3.5 mg Polymyxin B sulfate, USP 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 affected area • apply a small 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 Other Information • Store at controlled room temperature 59º - 86ºF (15º - 30ºC). • Protect from freezing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT 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 Helps 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 BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B 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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 63187-039-01 Triple Antibiotic Ointment FIRST AID ANTIBIOTIC (Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate Ointment) First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns Compare to the active ingredients in Neosporin®* NET WT 1 OZ (28 g) *This product is not affiliated with, manufactured by, or produced by the makers of Neosporin ® . 01791210G1 VC110203 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Made in India Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 63187-039-15
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 • 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 • over large areas of the body
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? 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.
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 • 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.WHEN USING THIS PRODUCT • do not use longer than 1 week unless directed by a doctor
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 Allergy alert: • do not use if allergic to any of the ingredients
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