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| Product NDC Code | 53329-938 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Povidone-iodine |
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| Type | Generic | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | SOLUTION | ||||||||||||
| RxCUI drug identifier | 211747 | ||||||||||||
| Application Number | part333E | ||||||||||||
| Labeler Name | Medline Industries, LP | ||||||||||||
| 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 7.5% (equivalent to 0.75% available 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 apply topically as needed follow with application of Medline Prep Solution and allow to dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium nonoxynol-4 sulfate, 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 for preparation of the skin prior to surgery helps to reduce bacteria that potentially can cause skin infection significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
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 AMMONIUM NONOXYNOL-4 SULFATE NONOXYNOL-5 POVIDONE-IODINE IODINE CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SODIUM HYDROXIDE WATER
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 PDP
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.Manufactuing Information Manufactured by: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA www.medline.com 1-800-MEDLINE (633-5463) REF: MDS093947 V1 RB22DYN
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 if you are allergic to iodine or any of the other ingredients in the product
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 ask a doctor if irritation and redness develop if condition persists for more than 72 hours
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions in pre-operative prepping, avoid “pooling” beneath the patient
Storage and handling
Information about safe storage and handling of the drug product.Other information protect from freezing, avoid excessive heat
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 if you are allergic to iodine or any of the other ingredients in the product When using this product prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions in pre-operative prepping, avoid “pooling” beneath the patient Stop use and ask a doctor if irritation and redness develop if condition persists for more than 72 hours 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