RxNorm Names
A3441-22 SPINAL 22G QUINCKE
()
c47916
[Smiths Medical ASD, Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a891657b-804a-4ec1-b09a-f6d143f2c3c3| Category | DEA Schedule | Marketing Status |
|---|---|---|
| MEDICAL DEVICE | Premarket Notification |
Drug Facts
3M DURAPREP SURGICAL
(iodine povacrylex and isopropyl alcohol)
solution
[3M Health Care]
Drug Facts
Active ingredientsIodine povacrylex (0.7% available iodine)
Isopropyl alcohol, 74% w/w
Antiseptic
Antiseptic
Usespatient preoperative skin preparation:
- for preparation of the skin prior to surgery
- helps reduce bacteria that potentially can cause skin infection
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

- 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
- 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.
- 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.
- 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
- 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.

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.
- 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.

| A3441-22 SPINAL 22G QUINCKE
regional anesthesia kit c47916 |
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| Labeler - Smiths Medical ASD, Inc. (137835299) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Smiths Medical ASD, Inc. | 137835299 | relabel, manufacture | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| 3M Company | 054236443 | manufacture | |
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