A3441-22 SPINAL 22G QUINCKE- c47916
A3441-22 SPINAL 22G QUINCKE by
Drug Labeling and Warnings
A3441-22 SPINAL 22G QUINCKE by is a Other medication manufactured, distributed, or labeled by Smiths Medical ASD, Inc., 3M Company. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Drug Facts
- PURPOSE
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WARNINGS
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
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DO NOT USE
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
- 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
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WHEN USING
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.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
A3441-22 SPINAL 22G QUINCKE
regional anesthesia kit c47916Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-9481 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:51688-9481-2 10 in 1 CASE 1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 APPLICATOR 6 mL Part 1 of 1 3M DURAPREP SURGICAL
iodine povacrylex and isopropyl alcohol solutionProduct Information Item Code (Source) NDC: 17518-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Iodine povacrylex (UNII: 6E43AWY083) (Iodine - UNII:9679TC07X4) Iodine povacrylex 6.02 mg in 1 mL Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol 636.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 17518-011-09 6 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021586 09/29/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K965017 10/14/2006 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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