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| Product NDC Code | 72663-561 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Welly bravery balm |
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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 | 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 Ingredients (in each gram) Bacitracin Zinc (400 units Bacitracin) Neomycin Sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 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 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 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 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 and 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.Welly Bravery Balm 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.Packaging 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
OINTMENT REFILLS FIRST AID welly Bravely Balm TRIPLE ACTION FIRST AID ANTIBIOTIC OINTMENT Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate Get the refills you need to build the Welly first aid kits you want. Triple antibiotic ointment helps prevent infection. Distributed by: Welly Health PBC Minneapolis, MN 55402 1-833-BE-WELLY Welly™ www.GetWelly.com Made in U.S.A RE19SAF
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 immediately
Storage and handling
Information about safe storage and handling of the drug product.Other Information • store at room temperature (do not freeze) • do not use any opened or torn packages
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: • in the eyes • internally • over large of the body • if you are allergic to any of the ingredients • longer than 1 week unless directed by a doctor Ask a doctor before use: • in case of deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if: • the condition persists or gets worse • a rash or other allergic reaction develops Keep out of 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