PurPrep
povidone iodine and isopropyl alcohol · Sponge · Topical
Active ingredient
BD PurPrep™ 10.5 mL Applicator Active Ingredients Isopropyl Alcohol 7.2% w/w Povidone-Iodine 8.3% w/w (0.83% available iodine) BD PurPrep™ 26 mL Applicator Active Ingredients Isopropyl Alcohol 72.5% w/w Povidone-iodine 8.3% w/w (0.83% available iodine)
Purpose
Purposes Antiseptic Antiseptic Purposes Antiseptic Antiseptic
Uses
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
Do not use
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 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
When using this product use in well ventilated area use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn When using this product use in well ventilated area 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
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions use in a well ventilated area do not allow solution to pool; tuck prep towels to absorb solution, and then remove remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available. Directions use in a well ventilated area do not allow solution to pool; tuck prep towels to absorb solution, and then remove 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 completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available.
Inactive ingredients
Inactive ingredients Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water Inactive ingredients Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water
Questions?
Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
Label text from the FDA structured product label by CareFusion 213 LLC (revised Oct 8, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Isopropyl Alcohol in 1 product
- Povidone-iodine in 1 product
PurPrep NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 54365-014 | Isopropyl Alcohol 725 mg/mL; Povidone-iodine 8.3 mg/mL Sponge | CareFusion 213 LLC | OTC MONOGRAPH DRUG |
PurPrep recalls
- D-0644-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0517-2026 May 13, 2026 · Class II · Ongoing
Lack of assurance of Sterility: potential product contamination - D-0518-2026 May 13, 2026 · Class II · Ongoing
Lack of assurance of Sterility: potential product contamination
Frequently asked questions
What is PurPrep used for?
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.
Who makes PurPrep?
PurPrep is listed by 1 labeler in the FDA NDC directory, including CareFusion 213 LLC.
Has PurPrep been recalled?
The FDA enforcement database lists 3 recalls for PurPrep, most recently D-0644-2026 (class ii): Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to…