3m Duraprep Surgical
Iodine Povacrylex And Isopropyl Alcohol
3m Company
Human Otc Drug
NDC 17518-0113m Duraprep Surgical also known as Iodine Povacrylex And Isopropyl Alcohol is a human otc drug labeled by '3m Company'. National Drug Code (NDC) number for 3m Duraprep Surgical is 17518-011. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in 3m Duraprep Surgical drug includes Iodine Povacrylex - 6.02 mg/mL Isopropyl Alcohol - 636.4 mg/mL . The currest status of 3m Duraprep Surgical drug is Active.
Drug Information:
| Drug NDC: | 17518-011 |
| 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 Duraprep Surgical |
| 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: | Iodine Povacrylex And Isopropyl Alcohol |
| 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: | IODINE POVACRYLEX - 6.02 mg/mL
ISOPROPYL ALCOHOL - 636.4 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: | NDA |
| 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: | 29 Sep, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | NDA021586 |
| 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: | 692866
1090522
|
| 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. |
| UNII: | 6E43AWY083
ND2M416302
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 17518-011-07 | 1 APPLICATOR in 1 CASE (17518-011-07) / 6 mL in 1 APPLICATOR | 29 Sep, 2006 | 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 antiseptic
Product Elements:
3m duraprep surgical iodine povacrylex and isopropyl alcohol iodine povacrylex iodine isopropyl alcohol isopropyl alcohol alcohol water
Indications and Usage:
Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection
Warnings:
Warnings for external use only. flammable, keep away from fire or flame. to reduce the risk of fire, prep carefully: solution contains alcohol and gives off flammable vapors do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). avoid getting solution into hairy areas. wet hair is flammable. hair may take up to 1 hour to dry. do not allow solution to pool remove solution-stained material from prep area figure-flame do not use on patients with known allergies to iodine or any other ingredients in this product on open wounds, on mucous membranes, or as a general skin cleanser in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism when using this product keep out of eyes, ears, and mouth. may cause serious injury if permitted to enter and remain. if contact occurs, flush with cold water right away and contact a doctor. to avoid skin injur
Read more...y, care should be taken when removing drapes, tapes, etcâ¦applied over film use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. on rare occasions, use of this product has been associated with skin blistering. 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. flammable, keep away from fire or flame. to reduce the risk of fire, prep carefully: solution contains alcohol and gives off flammable vapors do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). avoid getting solution into hairy areas. wet hair is flammable. hair may take up to 1 hour to dry. do not allow solution to pool remove solution-stained material from prep area figure-flame do not use on patients with known allergies to iodine or any other ingredients in this product on open wounds, on mucous membranes, or as a general skin cleanser in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism when using this product keep out of eyes, ears, and mouth. may cause serious injury if permitted to enter and remain. if contact occurs, flush with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etcâ¦applied over film use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. on rare occasions, use of this product has been associated with skin blistering. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product keep out of eyes, ears, and mouth. may cause serious injury if permitted to enter and remain. if contact occurs, flush with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etcâ¦applied over film use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. on rare occasions, use of this product has been associated with skin blistering. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions (follow all directions for use) at the end of the prep, discard any portion of the solution which is not required to cover the prep area. it is not necessary to use the entire amount available. getting patient ready for solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. if a wet shave is used, thoroughly remove all soap residues. activating the applicator: grasp product by wrapping hand and fingers around the labeled portion of the applicator. place thumb on the lever. with sponge face parallel to the floor, snap lever. allow all fluid to flow into sponge. when applying solution: do not scrub. paint a single, uniform application and do not reprep area. do not allow solution to pool. use sponge applicator to absorb excess solution and continue to apply a uniform coating. if solution accidentally get
Read more...s outside of prep area, remove excess with gauze. tuck prep towels as needed under both sides of the neck to absorb excess solution. remove towels before draping. avoid getting solution into hairy areas. wet hair is flammable. hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. otherwise, skin may adhere to itself. figure-no pooling after applying solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). solution will turn from a shiny to a dull appearance on skin alerting the user that the solution is completely dry and no longer flammable. while waiting for solution to completely dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. use sterile gauze to soak up pooled solution. do not blot because it may remove solution from skin. remove solution-stained materials. replace if necessary. figure-cautery after solution is completely dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all solution-stained materials are removed if incise drapes are used, apply directly to dry prep. on completion of surgical procedure, removal of incise drape will remove film. apply dressing following standard practices
Stop Use:
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. on rare occasions, use of this product has been associated with skin blistering.
Package Label Principal Display Panel:
Principal display panel â 6 ml applicator label 3m sterile eo ndc 17518-011-07 do not reuse 1. snap 2. paint, do not scrub duraprep tm surgical solution iodine povacrylex (0.7% available iodine) and isopropyl alcohol (74% w/w) patient preoperative skin preparation for head, neck, and small prep areas non-sterile solution applicator is sterile if package is intact ref 8635 0.2 fl oz ⢠6 ml external use only professional use only read drug facts information before use. made in u.s.a. by 3m health care 2510 conway ave., st. paul, mn 55144 1-800-228-3957 © 2015, 3m. all rights reserved. 3m and duraprep are trademarks of 3m. figure principal display panel â 6 ml applicator label
Principal display panel â 6 ml insert label 3m sterile eo ndc 17518-011-07 mal09032040xr duraprep tm surgical solution iodine povacrylex (0.7% available iodine) and isopropyl alcohol (74% w/w) patient preoperative skin preparation non-sterile solution applicator is sterile if package is intact for head, neck, and small prep areas do not reuse latex-free not made with natural latex single use duraprep surgical solution is a film-forming iodophor complex. each unit dose applicator contains 0.2 fl oz (6 ml) of solution which covers an approximate 8 in x 10 in area. 3m recommends all users participate in product in-service training prior to use. in-servicing is available on video, from your 3m sales representative, or at the 3m website (www.3m.com). ref 8635 0.2 fl oz ⢠6 ml 3m made in u.s.a. by 3m health care 2510 conway ave st. paul, mn 55144 1-800-228-3957 © 2015, 3m. all rights reserved. 3m and duraprep are trademarks of 3m figure principal display panel â 6 ml insert label
Further Questions:
Questions? call 1-800-228-3957 (monday to friday 7am â 6pm cst). www.3m.com.