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Product NDC Code | 54473-291 | ||||||
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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 | 1359363 | ||||||
Application Number | M004 | ||||||
Labeler Name | Melaleuca, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (each gram contains:) Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.One-of-a-Kind Formula The only formula that combines three antibiotics with the moisturizing properties of Melaleuca Oil. Effective Helps prevent bacterial infection in minor cuts, scrapes, and burns. Moisturizing Moisturizing ingredients rehydrate the skin.
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 1-3 times daily may be covered with a sterile bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Melaleuca Oil (T36-C5 (R) ), mineral oil, 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 the risk of infection in minor cuts scrapes burns
Purpose
Information about the drug product’s indications for use.Purpose antibiotic
Spl product data elements
Usually a list of ingredients in a drug product.Triple Antibiotic Bacitracin zinc and Neomycin and Polymyxin B sulfate TEA TREE OIL MINERAL OIL 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.Triple Antibiotic Ointment front.jpg Triple Antibiotic Ointment inside.jpg Triple Antibiotic Ointment box.jpg
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 over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult 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.
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. 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.
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