Poviofix Antiseptic
Povidone-iodine
Naturel Medikal Ilac Sanayi Ve Ticaret Limited Sirketi
Human Otc Drug
NDC 69249-000Poviofix Antiseptic also known as Povidone-iodine is a human otc drug labeled by 'Naturel Medikal Ilac Sanayi Ve Ticaret Limited Sirketi'. National Drug Code (NDC) number for Poviofix Antiseptic is 69249-000. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Poviofix Antiseptic drug includes Povidone-iodine - 100 mg/mL . The currest status of Poviofix Antiseptic drug is Active.
Drug Information:
| Drug NDC: | 69249-000 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Poviofix Antiseptic |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Povidone-iodine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Naturel Medikal Ilac Sanayi Ve Ticaret Limited Sirketi |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POVIDONE-IODINE - 100 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 25 Sep, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333E |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312564
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175486
M0011640
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 85H0HZU99M
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Antiseptic [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Iodine [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69249-000-00 | 1 BOTTLE in 1 CARTON (69249-000-00) / 1000 mL in 1 BOTTLE | 25 Sep, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antiseptic
Product Elements:
Poviofix antiseptic povidone-iodine alcohol glycerin polysorbate 20 sodium citrate povidone-iodine iodine
Indications and Usage:
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.
Warnings:
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.
Do Not Use:
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.
Dosage and Administration:
Directions surgical hand scrub (for use without water): 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) patient preoperative skin preparation: clean the area apply product to the operative site prior to surgery first-aid antiseptic: 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.
Stop Use:
Stop use and ask a doctor if irritation and redness develop. if condition persists for more than 72 hours consult a doctor.
Package Label Principal Display Panel:
Naturel for people poviofix antiseptic solution povidone-iodine 10% 33.8 fl oz (1.05 qt) (1 l)
Product label poviofix