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| Product NDC Code | 0116-0150 | ||||||||||||||||
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| Drug Name | Betadine |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||
| RxCUI drug identifier | 211108, 312564 |
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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.Active Ingredient Povidone-iodine, 10%
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 product to 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.Inactive Ingredients citric acid, disodium phosphate, glycerin, nonoxynol-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.Uses first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns
Purpose
Information about the drug product’s indications for use.Purpose First aid antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Betadine 10% Povidone-iodine CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE NONOXYNOL-9 WATER SODIUM HYDROXIDE POVIDONE-IODINE IODINE GLYCERIN
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.Principle Display Panel Betadine Antiseptic 67618-150-18 Betadine Antiseptic 67618-150-08 10% OTC Betadine 10% OTC Betadine 8oz
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.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.Other Information ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 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 bums ■ 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 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