PurPrep POVIDONE IODINE AND ISOPROPYL ALCOHOL CAREFUSION 213 LLC FDA Approved 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.
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Substance Isopropyl Alcohol
Route
TOPICAL
Applications
505G(A)(3)

Drug Facts

Composition & Profile

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)
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
Strengths
10.5 ml 7.2 % 8.3 % 0.83 % 26 ml 72.5 %
Quantities
5 ml 26 ml
Treats Conditions
Use For The Preparation Of The Patient S Skin Prior To Surgery Helps To Reduce Bacteria That Potentially Can Cause Skin Infection

Identifiers & Packaging

Container Type BOX
UNII
ND2M416302 85H0HZU99M
Packaging

BD PurPrep™ 10.5 mL Applicator Package Label BD PurPrep™ 10.5 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-41 Ref 960110 10.5 mL Package Label; BD PurPrep™ 10.5 mL Applicator Carton Label BD PurPrep™ 10.5 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-41 Ref 960110 Carton Label; BD PurPrep™ 26 mL Applicator Package Label BD PurPrep™ 26 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-42 Ref 960120 26 mL Package Label

Package Descriptions
  • BD PurPrep™ 10.5 mL Applicator Package Label BD PurPrep™ 10.5 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-41 Ref 960110 10.5 mL Package Label
  • BD PurPrep™ 10.5 mL Applicator Carton Label BD PurPrep™ 10.5 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-41 Ref 960110 Carton Label
  • BD PurPrep™ 26 mL Applicator Package Label BD PurPrep™ 26 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-42 Ref 960120 26 mL Package Label

Overview

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.

Indications & 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.

Dosage & Administration

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 & Precautions
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
Purpose

Purposes Antiseptic Antiseptic Purposes Antiseptic Antiseptic

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

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 & 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.

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)


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