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Product NDC Code | 0924-5610 | ||||||||
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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 | Acme United Corporation | ||||||||
Packages |
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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 5 mg (equivalent to 3.5 mg. of neomycin base) Polymyxin - B sulfate 5000 units Active ingredient (in each gram) Purpose Bacitracin Zinc 400 Units First Aid Antibiotic Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base) First Aid Antibiotic Polymyxin B Sulfate 5000 Units First Aid Antibiotic
Active ingredient (in each gram) | Purpose |
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Bacitracin Zinc 400 Units | First Aid Antibiotic |
Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base) | First Aid Antibiotic |
Polymyxin B Sulfate 5000 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 Adults and Children Clean the affected area. Apply a small amount of product (equal to the surface area of a fingertip) 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 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.Active ingredient (in each gram) Purpose Bacitracin Zinc 400 Units First Aid Antibiotic Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base) First Aid Antibiotic Polymyxin B Sulfate 5000 Units First Aid Antibiotic
Active ingredient (in each gram) | Purpose |
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Bacitracin Zinc 400 Units | First Aid Antibiotic |
Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base) | First Aid Antibiotic |
Polymyxin B Sulfate 5000 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 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.Carton Image Carton Image
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 Do not use • in the eyes •over large areas of the body •if you are allergic to any of the ingredients •longer than 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1.800.835.2263
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 allergic reaction occurs •condition persists for more than 7 days
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Store at 15°- 30°C (59°- 86°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 Do not use • in the eyes •over large areas of the body •if you are allergic to any of the ingredients •longer than 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns STOP USE AND ASK A DOCTOR IF •condition persists or gets worse •a rash or allergic reaction occurs •condition persists for more than 7 days Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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