3m Skin And Nasal Antiseptic
Povidone-iodine
3m Company
Human Otc Drug
NDC 17518-0603m Skin And Nasal Antiseptic also known as Povidone-iodine is a human otc drug labeled by '3m Company'. National Drug Code (NDC) number for 3m Skin And Nasal Antiseptic is 17518-060. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in 3m Skin And Nasal Antiseptic drug includes Povidone-iodine - 5 mg/mL . The currest status of 3m Skin And Nasal Antiseptic drug is Active.
Drug Information:
| Drug NDC: | 17518-060 |
| 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: | 3m Skin And Nasal 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: | 3m Company |
| 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 - 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: | 01 Jul, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | 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: | 3M Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 252965
|
| 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 |
|---|
| 17518-060-04 | 12 POUCH in 1 CARTON (17518-060-04) / 1 BOTTLE in 1 POUCH / 4 mL in 1 BOTTLE | 01 Jul, 2009 | 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:
3m skin and nasal antiseptic povidone-iodine povidone-iodine iodine lactic acid malic acid sodium hydroxide sodium iodide ceteareth-25 water xylitol lauramidopropylamine oxide
Indications and Usage:
Uses for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infections
Warnings:
Warnings for external use only. do not use if you have a known sensitivity to iodine or any other ingredient in this product. do not use in eyes. if product gets into eyes, flush immediately with water. do not use on infants less than 2 months old due to the risk of increased blood iodine levels. stop use and ask a doctor if significant irritation, sensitization or other allergic reactions occur. 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 if you have a known sensitivity to iodine or any other ingredient in this product. do not use in eyes. if product gets into eyes, flush immediately with water. do not use on infants less than 2 months old due to the risk of increased blood iodine levels. stop use and ask a doctor if significant irritation, sensitization or other allergic reactions occur. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions open package and remove bottle and swabs unscrew cap by turning cap counter-clockwise skin application: apply to clean dry skin. dip one swab into solution and stir vigorously for 10 seconds. withdraw the swab slowly to avoid wiping solution off during removal. scrub prep site for 2 minutes working from clean to dirty using both sides of the swab. repeat steps 2 & 3 using second swab. allow prep solution to dry. do not blot. nasal application: use a tissue to clean the inside of both nostrils including the inside tip of nostril. discard. tilting the bottle slightly, dip one swab into solution and stir vigorously for 10 seconds. withdraw the swab slowly to avoid wiping solution off during removal. insert swab comfortably into one nostril and rotate for 15 seconds covering all surfaces. then focus on the inside tip of nostril and rotate for an additional 15 seconds. (swab 1) using a new swab: repeat steps 2 & 3 with the other nostril. (swab 2) repeat the application in both no
Read more...strils using a fresh swab each time. (swabs 3 & 4) do not blow nose. if solution drips out of nose, it can be lightly dabbed with at tissue. figure figure figure
Stop Use:
Stop use and ask a doctor if significant irritation, sensitization or other allergic reactions occur.
Package Label Principal Display Panel:
Principal display panel â carton 3m skin and nasal antiseptic (povidone-iodine solution 5% w/w (0.5% available iodine) usp) patient preoperative skin preparation non-sterile solution contents: 12 pouches each pouch contains: 1 bottle 0.14 fl oz (4 ml) 4 sterile swabs applicators are sterile if swab pouch is intact made in u.s.a. by 3m health care 2510 conway ave. st. paul, mn 55144 3m is a trademark of 3m 1-800-228-3957 3m.com/medical 3m is a trademark of 3m © 2021, 3m. all rights reserved. 34-8726-9172-9 principal display panel â carton
Principal display panel â pouch label ndc 17518-060-04 not made with natural rubber latex do not reuse 3m skin and nasal antiseptic skin and nasal antiseptic (povidone-iodine solution 5% w/w (0.5% available iodine) usp) patient preoperative skin preparation non-sterile solution each pouch contains: 1 bottle 0.14 fl oz (4 ml) 4 sterile swabs applicators are sterile if swab pouch is intact ref 192401 principal display panel â pouch label
Further Questions:
Questions? call 1 800-228-3957 (monday to friday 7 am to 6 pm cst) www.3m.com