povidone iodine and isopropyl alcohol

FDA Drug Profile — PurPrep

Drug Details

Generic Name
povidone iodine and isopropyl alcohol
Brand Names
PurPrep
Application Number
505G(a)(3)
Sponsor
CareFusion 213 LLC
NDC Codes
1
Dosage Forms
SPONGE
Routes
TOPICAL
Active Ingredients
ISOPROPYL ALCOHOL, POVIDONE-IODINE

Indications and Usage

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

Warnings

Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: 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 Warnings 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