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| Product NDC Code | 0116-0160 | ||||
|---|---|---|---|---|---|
| Drug Name | Betadine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 108204, 238850 |
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| Application Number | M003 | ||||
| Labeler Name | Xttrium Laboratories, Inc. | ||||
| 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.Povidone-iodine, 5%
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.■ clean the affected area ■ spray a small amount of product on the area 1 to 3 times daily ■ may be covered with a sterile bandage ■ if bandaged, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.pareth 25-9, purified water, sodium hydroxide
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.first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns
Purpose
Information about the drug product’s indications for use.First aid antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Betadine Povidone-Iodine C12-15 PARETH-9 SODIUM HYDROXIDE WATER POVIDONE-IODINE IODINE
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.Betadine 3oz Spray
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Do Not Freeze
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.1-833-288-2684
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 ■ over large areas of the body ■ if you are allergic to povidone-iodine or any other ingredients in this preparation Ask a doctor before use if you have ■ deep or puncture wounds ■ serious burns ■ animal bites Stop use and ask a doctor if ■ the condition persists or gets worse ■ you need to use this product for more than 1 week Keep out of reach of children. If swallowed, get medical help or 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