Label: 3M SKIN AND NASAL ANTISEPTIC- povidone-iodine solution
- NDC Code(s): 17518-060-04
- Packager: 3M Health Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Povidone-Iodine USP, 5%Close
(0.5% Available Iodine)
- For preparation of the skin prior to surgery
- Helps reduce bacteria that potentially can cause skin infections
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.
- Open package and remove bottle and swabs
- Unscrew cap by turning cap counter-clockwise
- 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.
- 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.
- Other information
store at 20-25°C (68-77°F)Close
- Inactive Ingredients:
lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, steareth-100, water, xylitolClose
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Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144
© 2012, 3M. 3M is a trademark of 3M.Close
- Principal Display Panel – Carton
3M Skin and Nasal Antiseptic
(Povidone-Iodine Solution 5% w/w (0.5% available iodine) USP)
Patient Preoperative Skin Preparation
Each Pouch Contains:
- 1 Bottle 0.14 fl oz (4 mL)
- 4 Sterile Swabs
1 Bottle 0.14 fl oz (4 mL)
4 Sterile Swabs
3M™ Skin and Nasal Antiseptic
Povidone-Iodine Solution 5% w/w (0.5% Available Iodine) USP
Patient Preoperative Skin Preparation
Equivalent to 5mg available Iodine per milliliter
OTC Monograph Not Final
3M Health Care, St. Paul, MN 55144-1000Close
- INGREDIENTS AND APPEARANCE
3M SKIN AND NASAL ANTISEPTIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17518-060 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength lactic acid (UNII: 33X04XA5AT) malic acid (UNII: 817L1N4CKP) sodium hydroxide (UNII: 55X04QC32I) sodium iodide (UNII: F5WR8N145C) steareth-100 (UNII: 4OH5W9UM87) water (UNII: 059QF0KO0R) xylitol (UNII: VCQ006KQ1E) Lauramidopropylamine Oxide (UNII: I6KX160QTV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17518-060-04 12 in 1 CARTON 1 1 in 1 POUCH 1 4 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/01/2009 Labeler - 3M Health Care (006173082)