A3990 SINGLE SHOT EPIDURAL

Smiths Medical ASD, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts

FULL PRESCRIBING INFORMATION

Drug Facts

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

Drug Facts

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

Purpose

Antiseptic

Antiseptic

patient 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.

• 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.

• 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).

ethyl alcohol, water

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

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