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| Product NDC Code | 69249-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Poviofix 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 | NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI | ||||
| 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% Purpose Antiseptic
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 Surgical hand scrub (for use without water): Patient preoperative skin preparation: First-aid antiseptic: clean under nails with a nail pick nails should be maintained with a 1 millimeter free edge place a ‘palmful’ (5 grams) of product in one hand spread on both hands, paying particular attention to the nails, cuticles, and interdigital spaces, and rub into the skin until dry (approximately 1 to 2 minutes) place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist, and rub into the skin until dry (approximately 30 seconds) clean the area apply product to the operative site prior to surgery clean the affected area. May be covered with a sterile bandage. If bandaged, let dry first. If used as a wet compress bandage lightly. Keep bandage wet with solution.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients denatured ethyl alcohol, glycerin, polysorbate 20, potassium iodine, trisodium citrate
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 Surgical hand scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care. Patient preoperative skin preparation: for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection. First aid to help decrease 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.POVIOFIX Antiseptic POVIDONE-IODINE ALCOHOL GLYCERIN POLYSORBATE 20 SODIUM CITRATE 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.NATUREL For People POVIOFIX Antiseptic Solution Povidone-iodine 10% 33.8 fl oz (1.05 qt) (1 l)
Product Label PovioFix
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.Drug Facts
TO REPORT A SERIOUS ADVERSE EVENT CONTACT [?] YAKUPLU DISTRICT, BEYSAN INDUSTRIAL SITE, BIRLIK STR, NAKIPOGLU CENTRE NO 12. FLOOR 1. BEYLIKDUZU/ISTANBUL/TURKEY TEL: (0212)476 28 68 /476 58 88 FAX: (0212)476 08 98 [email protected] MADE IN TURKEY
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 you have deep or puncture wounds, animal bites, or 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 - over large areas of the body - longer than 1 week unless directed by a doctor - if you are allergic 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. 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 consult a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other information keep the product under 77°F (25°F) and away from food and children keep product sealed after opening
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 - over large areas of the body - longer than 1 week unless directed by a doctor - if you are allergic to iodine Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. 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