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| Product NDC Code | 17518-060 | ||||
|---|---|---|---|---|---|
| Drug Name | 3m skin and nasal antiseptic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| Application Number | M003 | ||||
| Labeler Name | Solventum US LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Povidone-Iodine USP, 5% (0.5% Available Iodine)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 nostrils 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: ceteareth-25, lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, water, xylitol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For preparation of the skin prior to surgery Helps reduce bacteria that potentially can cause skin infections
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.3M Skin and Nasal Antiseptic Povidone-Iodine Povidone-Iodine Iodine Lactic Acid Malic Acid Sodium Hydroxide Sodium Iodide ceteareth-25 Water Xylitol Lauramidopropylamine Oxide
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel – 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 – Carton
Principal Display Panel – 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 – Pouch Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information store at 20-25°C (68-77°F)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1 800-228-3957 (Monday to Friday 7 am to 6 pm CST) www.3M.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if significant irritation, sensitization or other allergic reactions occur.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API