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Product NDC Code | 60913-999 | ||||
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Drug Name | Povidone iodine prep |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
RxCUI drug identifier | 797730 | ||||
Application Number | M003 | ||||
Labeler Name | PHOENIX HEALTHCARE SOLUTIONS, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Povidone Iodine USP 10% v/v
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: For preparation of the skin prior to surgery clean the affected area apply a small amount of this product on the area For use as a first aid antiseptic clean the affected area apply a small amount of this product on the area 1-3 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, glycerin, Makon 8, 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 Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
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 Povidone Iodine CITRIC ACID MONOHYDRATE GLYCERIN 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.Principal Display Panel Phoenix Healthcare Solutions LLC An Innovative Medical Manufacturer NDC 60913-999-02 200 Individual Pads Povidone Iodine Prep Pads Medium For Individual, Professional and Hospital Use Saturated with 10% Povidone Iodine for external use only Latex Free PIN DOT WOVEN Label
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.Consult a doctor in case of deep or puncture wounds animal bites 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 use on individuals who are allergic or sensitive to iodine apply over large areas of the body use as a first aid antiseptic longer than 1 week unless directed by a doctor. Discontinue use if irritation and redness develop.
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.
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 consult a doctor if the condition persists or gets worse.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature: 59 o - 86 o F (15 o - 30 o C)
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 use on individuals who are allergic or sensitive to iodine apply over large areas of the body use as a first aid antiseptic longer than 1 week unless directed by a doctor. Discontinue use if irritation and redness develop. Consult a doctor in case of deep or puncture wounds animal bites serious burns Stop use and consult a doctor if the condition persists or gets worse. 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