Povidone Iodine
Povidone Iodine Oral Rinse 0.5%
Humco Holding Group, Inc.
Human Otc Drug
NDC 0395-9136Povidone Iodine also known as Povidone Iodine Oral Rinse 0.5% is a human otc drug labeled by 'Humco Holding Group, Inc.'. National Drug Code (NDC) number for Povidone Iodine is 0395-9136. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Povidone Iodine drug includes Povidone-iodine - 5 mg/mL . The currest status of Povidone Iodine drug is Active.
Drug Information:
| Drug NDC: | 0395-9136 |
| 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: | Povidone 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: | Povidone Iodine Oral Rinse 0.5% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Humco Holding Group, Inc. |
| 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 - 5 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: | 06 Jan, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | part333A |
| 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: | Humco Holding Group, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 314935
|
| 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 |
|---|
| 0395-9136-23 | 20 mL in 1 CONTAINER (0395-9136-23) | 01 Oct, 2021 | N/A | No |
| 0395-9136-98 | 237 mL in 1 CONTAINER (0395-9136-98) | 06 Jan, 2021 | 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 oral antiseptic
Product Elements:
Povidone iodine povidone iodine oral rinse 0.5% menthol saccharin sodium anhydrous citric acid glycerin sodium hydroxide water propylene glycol peppermint povidone-iodine iodine
Indications and Usage:
Use for preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.
Warnings:
Warnings do not use this product for more than 7 days unless directed by a dentist of doctor in children under 12 years of age unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredients in this product if you have any thyroid conditions
Do Not Use:
Warnings do not use this product for more than 7 days unless directed by a dentist of doctor in children under 12 years of age unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredients in this product if you have any thyroid conditions
When Using:
When using this product do not get into eyes. if contact occurs, rinse eyes thoroughly with water. if iritation persists, consult a doctor. swallow. use with hydrogen peroxide.
Dosage and Administration:
Directions use full strength. apply 10 to 20 milliliters of solution to the operative site. instruct the patient to rinse for 30 seconds and then spit out. wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. instruct the patient to rinse again for 30 seconds and then spit out. with a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. instruct the patient to spit out the solution after the irrigation procedure.
Stop Use:
Stop use and consult a doctor if symptoms do not improve in 7 days. irritation, pain or redness persists or worsens. swelling, rash or fever develops.
Package Label Principal Display Panel:
Purdue oral rinse label betadine 20 ml oral rinse.jpg