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| Product NDC Code | 59050-651 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Povidone-iodine paint solution |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 312564 | ||||||
| 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 10%w/w 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 apply locally as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Hydroxyethyl cellulose, nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, citric acid, purifed 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 antiseptic skin preparation
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 Paint Solution POVIDONE-IODINE HYDROXYETHYL CELLULOSE, UNSPECIFIED NONOXYNOL-10 POTASSIUM IODIDE SODIUM HYDROXIDE GLYCERIN CITRIC ACID MONOHYDRATE 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:89ml Label14
Package Labeling:118ml Label15
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 for hospital or professional use only
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 if allergic to Iodine 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. In case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately. Avoid pooling beneath patient.
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 redness,irritation,swelling or pain persist or increases infection occurs
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 Do not use if allergic to Iodine do not use in the eyes Stop use and ask a doctor if redness,irritation,swelling or pain persist or increases infection occurs Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately. Avoid pooling beneath patient.
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