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| Product NDC Code | 24385-053 | ||||
|---|---|---|---|---|---|
| Drug Name | Povidone iodine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 312564 | ||||
| Application Number | M003 | ||||
| Labeler Name | Amerisource Bergen | ||||
| 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/v (equivalent to 1% titratable 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 Clean the affected area Apply a small amount of this product to 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 dibasic sodium phosphate nonoxynol-9 glycerin purified water sofium 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.USE First aid antiseptic to help prevent the risk of 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 povidone-iodine CITRIC ACID MONOHYDRATE GLYCERIN SODIUM HYDROXIDE WATER SODIUM PHOSPHATE, DIBASIC NONOXYNOL-9 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.LABEL INFORMATION GNP Povidone.jpg
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Updated to match new 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.Ask 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
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Questions or comments? 1-800-662-3435 www.goodneighborpharmacy.com
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.Discontinue use and ask a doctor if condition persists or gets worse for use longer than 1 week
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Store at room temperature: 15° - 30° C (59° - 86° F)
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 Discontinue use and ask a doctor if condition persists or gets worse for use longer than 1 week Ask a doctor in case of deep or puncture wounds animal bites serious burns 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