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| Product NDC Code | 72663-560 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | 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 | ||||||
| Application Number | M004 | ||||||
| Labeler Name | Welly Health PBC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each gram) Bacitracin zinc 400 units Neomycin sulfate (3.5 mg Neomycin) Polymyxin B sulfate 5000 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 1 to 3 times daily may cover with a sterile bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients petrolatum Welly Health PBC, Minn., MN 55402 1-833-BE-WELLY
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, and burns
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antibiotics
Spl product data elements
Usually a list of ingredients in a drug product.Antibiotic bacitracin zinc, neomycin sulfate, 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.Principal Display Panel - Antibiotic Pouch Label Welly™ Triple Antibiotic Ointment 0.5g/ 1/57 OZ Principal Display Panel - Antibiotic Pouch Label
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 internally in eyes over large areas of the body or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if you are allergic to any of the ingredients
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 ingested, 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, ask a doctor a rash or allergic reactions develops condition worsens or persists
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 External use only. Do not use internally in eyes over large areas of the body or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if you are allergic to any of the ingredients Stop use, ask a doctor a rash or allergic reactions develops condition worsens or persists Keep out of reach of children. If ingested, 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