Purprep Sponge
FDA Label NDC 54365-014

Isopropyl alcohol 72.5% w/w

Povidone-iodine 8.3% w/w (0.83% available iodine)

Antiseptic

Antiseptic

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

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

T o reduce risk of fire, PREP CAREFULLY:

• do not use 26-mL applicator for head and neck surgery
• solution contains alcohol and gives off flammable vapors.
• avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
• 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)
• do not allow the solution to pool
• remove wet materials from prep area

Do not use

• on children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption. Daily use of iodine on newborn infants may increase blood iodine level.
• on open skin wounds or as a general skin cleanser
• in the eyes or for prepping mucous membranes
• on iodine sensitive patients

When using this product use in well ventilated area.

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These maybe signs of a serious condition.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• to reduce risk of fire the following strategies are recommended:
  • 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 a well ventilated area
  • 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; tuck prep towels to absorb solution, and then remove.
  • remove wet materials from prep area
  • drape after solution is completely dry
  • do not use 26 mL applicator for head and neck surgery
  • remove applicator from package; do not touch sponge
  • hold the applicator with the sponge down. Pinch wings only once to activate the ampules and release the antiseptic.
  • wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
  • apply thin, even coat to operative site. Do not blot.
  • discard prepping materials, including solution soaked materials.
  • wait until prep is dry (3 minutes or more) on skin before draping or using ignition sources

• store between 15-30 ^o C (59-86 ^o F)
• avoid excessive heat above 40 ^o C (104 ^o F)

Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water

Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)