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| Product NDC Code | 53329-939 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Povidone-iodine topical antiseptic |
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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 | Medline Industries, LP | ||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Povidone Iodine 10% (equivalent to 1% 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 Clean the affected area. For preparation of the skin prior to surgery: apply product to the operative site prior to surgery For first aid antiseptic: apply a small amount of this product on the area 1 to 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, 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 healthcare antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent 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 Topical Antiseptic Povidone-Iodine CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE NONOXYNOL-9 SODIUM HYDROXIDE 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.Packaging Labels PDP V2 RB24HND
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: Medline Industries, LP Three Lakes Drive, Northifeld, IL 60093 USA Made in USA www.medline.com 1-800-MEDLINE (633-5463) REF: MDS093941 V1 RB22DYN REF: 55114 V2 RB24HND
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 longer than 1 week unless directed by a doctor on individuals who are allergic or sensitive to iodine or 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.
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 condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or serious burns
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 longer than 1 week unless directed by a doctor on individuals who are allergic or sensitive to iodine or apply over large areas of the body Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or 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