Medline Nasal Antiseptic Swabs
Povidone Iodine Swabstick
Medline Industries, Lp
Human Otc Drug
NDC 53329-497Medline Nasal Antiseptic Swabs also known as Povidone Iodine Swabstick is a human otc drug labeled by 'Medline Industries, Lp'. National Drug Code (NDC) number for Medline Nasal Antiseptic Swabs is 53329-497. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Medline Nasal Antiseptic Swabs drug includes Povidone-iodine - 10 mg/mL . The currest status of Medline Nasal Antiseptic Swabs drug is Active.
Drug Information:
| Drug NDC: | 53329-497 |
| 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: | Medline Nasal Antiseptic Swabs |
| 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 Swabstick |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medline Industries, Lp |
| 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 - 10 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: | 15 Jan, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | 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: | Medline Industries, LP
|
| 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 |
|---|
| 53329-497-26 | 10 mL in 1 PACKET (53329-497-26) | 15 Jan, 2018 | N/A | No |
| 53329-497-42 | 2 PACKET in 1 BOX (53329-497-42) / 10 mL in 1 PACKET (53329-497-26) | 15 Jan, 2018 | N/A | No |
| 53329-497-66 | 250 PACKET in 1 CASE (53329-497-66) / 10 mL in 1 PACKET (53329-497-26) | 15 Jan, 2018 | 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:
Medline nasal antiseptic swabs povidone iodine swabstick dimethicone silicon dioxide sodium phosphate, dibasic, anhydrous hydroxyethyl cellulose (2000 mpa.s at 1%) nonoxynol-10 glycerin water povidone-iodine iodine
Indications and Usage:
Uses ⢠antiseptic skin preparation ⢠helps reduce bacteria that can potentially cause skin infections
Warnings:
Warnings for external use only do not use ⢠if allergic to iodine ⢠in the eyes ⢠on children less than 3 years old ask a doctor before use if injuries are ⢠deep or puncture wounds ⢠serious burns stop use and ask a doctor if ⢠redness, irritation, swelling or pain persists or increases ⢠infection occurs keep out of reach of children. in case of accidental ingestion, seek professional assistance or consult a poison control center immediately. avoid excessive heat. store at room temperature.
Do Not Use:
Warnings for external use only do not use ⢠if allergic to iodine ⢠in the eyes ⢠on children less than 3 years old ask a doctor before use if injuries are ⢠deep or puncture wounds ⢠serious burns stop use and ask a doctor if ⢠redness, irritation, swelling or pain persists or increases ⢠infection occurs keep out of reach of children. in case of accidental ingestion, seek professional assistance or consult a poison control center immediately. avoid excessive heat. store at room temperature.
Dosage and Administration:
Directions nasal application: use a tissue to clean the inside of both nostrils, including the inside tip of nostril. discard. insert swab comfortably into one nostril and rotate for 30 seconds, covering all surfaces. discard swabstick. using a 2nd swab, repeat step 2 with the other nostril. repeat the application in both nostrils, using the 3rd and 4th swabs. do not blow nose. if solution drips, gently wipe with a tissue. figure figure figure figure figure
Stop Use:
Stop use and ask a doctor if ⢠redness, irritation, swelling or pain persists or increases ⢠infection occurs
Package Label Principal Display Panel:
Package label label front label back