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| Product NDC Code | 59050-658 | ||||
|---|---|---|---|---|---|
| Drug Name | Povidone-iodine prep sterile |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPONGE | ||||
| RxCUI drug identifier | 797730 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Changzhou Maokang Medical Products 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 ingredient Povidone-Iodine USP 10% Purpose Antiseptic
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 area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water
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.Use For preparation prior to surgery Helps to reduce bacteria that can potentially 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.Povidone-Iodine Prep Sterile Povidone-Iodine CITRIC ACID MONOHYDRATE HYDROXYETHYL CELLULOSE, UNSPECIFIED NONOXYNOL-10 GLYCERIN SODIUM HYDROXIDE POTASSIUM IODIDE 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.Package Labeling: Label0
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
Other information • 1% titratable iodine • latex free • for hospital or professional use only
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if injuries are • deep wounds • puncture wounds • serious burns
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in the eyes
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 or gets in eyes, get medical help or contact a 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 • irritation and redness develop • condition persists for more than 72 hours • infection occurs Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.
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 apply to persons allergic to iodine Do not use in the eyes Ask a doctor before use if injuries are • deep wounds • puncture wounds • serious burns Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours • infection occurs Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation. Keep out of reach of children. If swallowed or gets in eyes, 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