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PurPrep

povidone iodine and isopropyl alcohol · PurPrep is an antiseptic (over-the-counter) containing povidone iodine and isopropyl alcohol, made by CareFusion 213 LLC.

Type
Over the counter
Drug class
Antiseptic
Route
Topical
Manufacturers
1

for the preparation of the patient's skin prior to surgery.

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Active ingredients

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

Antiseptic Antiseptic

Purposes Antiseptic Antiseptic

Uses

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.

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.

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

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

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

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

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.

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?

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)

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Sponge725 mg/mL / 8.3 mg/mLtopical1

Manufacturers and labels

1 FDA label

  • CareFusion 213 LLCShown here505G(a)(3) · Label 10/08/2025 · NDC 54365-014Full label

PurPrep: common questions

What is PurPrep used for?
for the preparation of the patient's skin prior to surgery.
Is PurPrep a prescription drug?
No. PurPrep is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as PurPrep?
Yes. Other FDA-listed products with the same active ingredients include Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA), Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w).
Who makes PurPrep?
CareFusion 213 LLC lists PurPrep with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 10/08/2025 · Label text is shown as published by the manufacturer. Not medical advice

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