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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 | ||||||||||||||||
| 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 ■ single use only ■ clean the operative site prior to surgery ■ apply product and allow to dry ■ may be covered with a sterile bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient 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 Patient pre-operative skin preparation ■ for preparation of the skin prior to surgery ■ helps reduce bacteria that potentially can cause skin infection
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Betadine 10% Povidone-iodine CITRIC ACID MONOHYDRATE NONOXYNOL-9 POVIDONE-IODINE IODINE SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE GLYCERIN WATER SODIUM HYDROXIDE
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.10% Professional .5oz 10% Professional 4oz 10% Professional 8oz 10% Betadine 16oz 10% Betadine 1 gallon
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.Other information ■ store in original container ■ 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 ■ if you are allergic to povidone-iodine or any other ingredients in this preparation When using this product ■ prolonge exposure to wet solution may cause irritation or, rarely severe skin reactions ■ in pre-operative prepping, avoid "pooling" beneath the patient Stop use and ask a doctor if ■ irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition. 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