Mckesson Pvp Prep Solution
Povidone-iodine
Mckesson Medical-surgical
Human Otc Drug
NDC 68599-3500Mckesson Pvp Prep Solution also known as Povidone-iodine is a human otc drug labeled by 'Mckesson Medical-surgical'. National Drug Code (NDC) number for Mckesson Pvp Prep Solution is 68599-3500. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Mckesson Pvp Prep Solution drug includes Povidone-iodine - 1 mg/10mL . The currest status of Mckesson Pvp Prep Solution drug is Active.
Drug Information:
| Drug NDC: | 68599-3500 |
| 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: | Mckesson Pvp Prep Solution |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Mckesson Pvp Prep |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Solution |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Mckesson Medical-surgical |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 1 mg/10mL
|
| 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: | 17 Oct, 2016 |
| 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: | McKesson Medical-Surgical
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0612479214002
0612479213982
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 68599-3500-2 | 12 BOTTLE in 1 CASE (68599-3500-2) / 473 mL in 1 BOTTLE (68599-3500-1) | 20 Oct, 2016 | N/A | No |
| 68599-3500-6 | 4 BOTTLE in 1 CASE (68599-3500-6) / 3800 mL in 1 BOTTLE (68599-3500-5) | 20 Oct, 2016 | 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:
Mckesson pvp prep solution povidone-iodine citric acid monohydrate sodium phosphate, dibasic, anhydrous glycerin water sodium citrate polysorbate 80 povidone-iodine iodine mckesson pvp prep solution povidone-iodine citric acid monohydrate sodium phosphate, dibasic, anhydrous glycerin water sodium citrate polysorbate 80 povidone-iodine iodine
Indications and Usage:
Uses health-care antiseptic preparation of the skin prior to surgery. first aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
Warnings:
Warnings for external use only do not use in the eyes use as a first aid antiseptic longer than one week use on individuals who are allergic or sensitive to iodine use on deep or puncture wounds use on animal bites use on serious burns apply over large areas of the body stop use and ask a doctor if conditions persists or gets worse irritation and redness develop and persists for more than 72 hours keep out of the 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 use as a first aid antiseptic longer than one week use on individuals who are allergic or sensitive to iodine use on deep or puncture wounds use on animal bites use on serious burns apply over large areas of the body stop use and ask a doctor if conditions persists or gets worse irritation and redness develop and persists for more than 72 hours keep out of the reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions for preparation of the skin prior to surgery apply product to the operative site prior to surgery as a first aid antiseptic clean the affected area apply a small amount of this product on the area 1-3 times daily may be covered with a sterile bandage if bandaged, let dry first
Stop Use:
Stop use and ask a doctor if conditions persists or gets worse irritation and redness develop and persists for more than 72 hours
Package Label Principal Display Panel:
Principal display panel - mckesson pvp prep solution 4 fl oz carton label ndc 68599-3502-1 mckesson pvp prep solution mfr# 039 usp 10% povidone iodine topical antiseptic microbicide net contents 4 fl oz (118 ml) 039 each
Principal display panel - mckesson pvp prep solution 4 fl oz label ndc 68599-3502-2 mckesson pvp prep solution usp 10% povidone iodine net contents 4 fl oz (118 ml) 36 bottles per case do not store above 77°f (25°c). do not store below 68°f (20°c). not made with natural rubber latex. distributed by mckesson medical-surgical inc. richmond. va 23233 pvn b0520 made in mexico lot exp mfr# 039 039 case
Principal display panel - mckesson pvp prep solution 16 fl oz carton label ndc 68599-3500-1 mckesson pvp prep solution usp 10% povidone iodine topical antiseptic microbicide net contents 16 fl oz (473 ml) mfr# 035 035 each
Principal display panel - mckesson pvp prep solution 16 fl oz label ndc 68599-3500-2 mckesson pvp prep solution usp 10% povidone iodine net contents 16 fl oz (473 ml) 12 bottles per case do not store above 77°f (25°c). do not store below 68°f (20°c). not made with natural rubber latex. distributed by mckesson medical-surgical inc. richmond. va 23233 pvn b0520 made in mexico lot exp mfr# 035 035 case
Principal display panel - mckesson pvp prep solution 1 gal carton label ndc 68599-3500-5 mckesson pvp prep solution usp 10% povidone iodine topical antiseptic microbicide net contents 1 gal (3.8 l) mfr# 036 036 each
Principal display panel - mckesson pvp prep solution 1 gal label ndc 68599-3500-6 mckesson pvp prep solution usp 10% povidone iodine net contents 1 gal (3.8 l) 4 bottles per case do not store above 77°f (25°c). do not store below 68°f (20°c). not made with natural rubber latex. distributed by mckesson medical-surgical inc. richmond. va 23233 pnv b0520 made in mexico lot exp mfr# 036 036 case
Principal display panel - mckesson pvp prep solution 8 fl oz. label ndc 68599-3502-5 mckesson pvp prep solution usp 10% povidone iodine topical antiseptic microbicide net contents 8 fl oz (237 ml) mfr # 034 034 each
Principal display panel - mckesson pvp prep solution 8 fl. oz. carton label ndc 68599-3502-6 mckesson pvp prep solution usp 10% povidone iodine net contents 8 fl oz (237 ml) 24 bottles per case do not store above 77°f (25°c). do not store below 68°f (20°c). not made with natural rubber latex. distributed by mckesson medical-surgical inc. richmond. va 23233 pvn b0520 made in mexico lot exp mfr# 034 034 case