Your browser does not support JavaScript! A3441-22 SPINAL 22G QUINCKE () C47916 [SMITHS MEDICAL ASD, INC.]
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A3441-22 SPINAL 22G QUINCKE () c47916
[Smiths Medical ASD, Inc.]


Category DEA Schedule Marketing Status
MEDICAL DEVICE Premarket Notification
Drug Label Sections

Drug Facts

3M DURAPREP SURGICAL (iodine povacrylex and isopropyl alcohol) solution
[3M Health Care]

Drug Facts

Active ingredients

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

Purpose

Antiseptic

Antiseptic

Uses

patient preoperative skin preparation:

  • for preparation of the skin prior to surgery
  • helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only. Flammable, keep away from fire or flame.

To reduce the risk of fire, PREP CAREFULLY:

  • do not use 26-mL applicator for head and neck surgery
  • do not use on an area smaller than 8 in. x 10 in. Use a small applicator instead.
  • 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
flame figure 1

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, etc…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.

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:
  • with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into the sponge.
  • wait for fluid level to reach indicator line of applicator barrel
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 gets outside of prep area, remove excess with gauze.
  • clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.)
  • 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.
pooling figure 1

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.
cautery figure 1


Other information
  • store between 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
  • solution is not water soluble and may stain. Therefore, avoid contact with reusable items (basins, instruments).

Inactive ingredients

ethyl alcohol, water

Questions?

call 1-800-228-3957 (Monday to Friday 7AM – 6PM CST). www.3M.com.

Package Label Display Panel

Surgical Solution 1

Package Label Display Panel

A3441-22

A3441-22 SPINAL 22G QUINCKE 
regional anesthesia kit c47916
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-9481
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-9481-210 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 APPLICATOR 6 mL
Part 1 of 1
3M DURAPREP SURGICAL 
iodine povacrylex and isopropyl alcohol solution
Product Information
Item Code (Source)NDC:17518-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Iodine povacrylex (Iodine) Iodine povacrylex6.02 mg  in 1 mL
Isopropyl alcohol (Isopropyl alcohol) Isopropyl alcohol636.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17518-011-096 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158609/29/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501710/14/2006
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299relabel, manufacture
Establishment
NameAddressID/FEIBusiness Operations
3M Company054236443manufacture

Revised: 10/2012
 
Smiths Medical ASD, Inc.

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