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| Product NDC Code | 34645-4009 | ||||
|---|---|---|---|---|---|
| Drug Name | Povidone iodine |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 314188 | ||||
| Application Number | M005 | ||||
| Labeler Name | Jianerkang Medical Co., Ltd | ||||
| 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 Povidone Iodine, USP 7.5% (0.75% available Iodine)
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 Patient preoperative prep use full strength apply solution saturated sponge to operative site scrub in circular motion for 5 minutes starting at incision site and move outward blot with sterile towel follow with application of topical solution
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients alkyl polyglucoside, citric acid, nonoxynol - 10, 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 For preparation of skin and mucous membranes prior to surgery
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.Povidone Iodine Povidone Iodine CITRIC ACID MONOHYDRATE NONOXYNOL-10 WATER SODIUM HYDROXIDE 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.Package label Pouch Label
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 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 and ask a doctor if Skin shows symptoms of irritation, sensitivity, redness, pain or swelling
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature avoid excessive heat (above104oF/40oC) protect from freezing latex free
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 Avoid use on persons allergic to iodine
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