Povidine Iodine
Dynarex Corporation
Human Otc Drug
NDC 67777-420Povidine Iodine is a human otc drug labeled by 'Dynarex Corporation'. National Drug Code (NDC) number for Povidine Iodine is 67777-420. This drug is available in dosage form of Swab. The names of the active, medicinal ingredients in Povidine Iodine drug includes Povidone-iodine - 10 g/100g . The currest status of Povidine Iodine drug is Active.
Drug Information:
| Drug NDC: | 67777-420 |
| 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: | Povidine Iodine |
| 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: | Povidine Iodine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dynarex Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Swab |
| 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 - 10 g/100g
|
| 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 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: | 13 Sep, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| 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: | part333C |
| 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: | Dynarex Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 797730
|
| 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 |
|---|
| 67777-420-01 | .3 g in 1 POUCH (67777-420-01) | 13 Sep, 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:
Povidine iodine povidine iodine citric acid acetate glycerin polysorbate 80 sodium citrate sodium phosphate, dibasic, anhydrous water povidone-iodine iodine
Indications and Usage:
Uses antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns. for preparation of the skin prior to surgery. helps reduce bacteria that can potentially cause skin infections.
Warnings:
Warnings for external use only do not use in the eyes. as a first aid antiseptic for more than 1 week. over large areas of the body. ask a doctor before use if you have: deep or puncture wounds animal bites serious burns stop use and ask a doctor if condition worsens or persists for more than 72 hours irritation and redness develop 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. as a first aid antiseptic for more than 1 week. over large areas of the body. ask a doctor before use if you have: deep or puncture wounds animal bites serious burns stop use and ask a doctor if condition worsens or persists for more than 72 hours irritation and redness develop keep out of reach of children if swallowed, get medical help or contact a poison control center right away
Dosage and Administration:
Directions: tear at notch remove applicator use only once. as a first aid antiseptic clean affected area apply 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first.
Stop Use:
Stop use and ask a doctor if condition worsens or persists for more than 72 hours irritation and redness develop
Package Label Principal Display Panel:
Principal display panel reorder no. 1108 povidone - iodine prep pads antiseptic/germicide for external use only dynarex 100 medium label