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| Product NDC Code | 52380-1905 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Aplicare povidone-iodine |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 312564, 617973 |
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| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Aplicare Products, LLC | ||||||
| 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%
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 • citric acid • disodium phosphate • nonoxynol-9 • sodium hydroxide • 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.Uses antiseptic skin preparation single use when used for patient preoperative skin preparation and/or preinjection indications.
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.Aplicare Povidone-Iodine Povidone-Iodine CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC SODIUM HYDROXIDE NONOXYNOL-9 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 Label Label RL17HND
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.Manufacturing Information Manufactured by: Aplicare Products, LLC 550 Research Parkway, Meriden, CT 06450 USA Made in USA with domestic and foreign materials 1-800-633-5463 REF: APL82332 RL17HND
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 or 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 on individuals allergic or sensitive to iodine
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information 1% titratable iodine not made with Natural Rubber Latex for hospital or professional use only
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1 800-633-5463 Monday - Friday 8:30 AM -5:00 PM EST
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 infection occurs redness, irritation, swelling or pain persists or increases
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 "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation. Do not use in the eyes on individuals allergic or sensitive to iodine Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if infection occurs redness, irritation, swelling or pain persists or increases Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
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