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| Product NDC Code | 39892-0804 | ||||
|---|---|---|---|---|---|
| Drug Name | Medichoice pvp swabsticks |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 797730 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Owens and Minor | ||||
| 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% 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 For preparation of the skin prior to surgery For use as a first aid antiseptic Clean the treatment area Remove swab by the stick Apply to the operative site prior to surgery. Clean the treatment area Apply a small amount on the treatment area 1-3 times daily May be covered with a sterile bandage Let dry before covering.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric Acid, Purified water, Sodium phosphate dibasic
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 Healthcare topical antiseptic for preparation of the skin prior to surgery Topical first aid antiseptic to help reduce 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.MediChoice PVP Swabsticks POVIDONE-IODINE CITRIC ACID ACETATE WATER SODIUM PHOSPHATE, DIBASIC 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.MediChoice PVP Swabsticks (3's) (39892-0804-1) Label
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 who are allergic or sensitive to iodine over large areas of the body as a first aid antiseptic longer than one week unless directed by a doctor.
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 or gets worse infection occurs deep or puncture wounds animal bites serious burns. Consult a doctor in case of
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 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 on individuals who are allergic or sensitive to iodine over large areas of the body as a first aid antiseptic longer than one week unless directed by a doctor. Stop use and ask a doctor if irritation and redness develop if condition persists or gets worse infection occurs deep or puncture wounds animal bites serious burns. Consult a doctor in case of 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