Bd Purprep™ 10.5 Ml Applicator

Bd Purprep™ 10.5 Ml Applicator
SPL v12
SPL
SPL Set ID a1c6e118-7861-c8d0-e053-2995a90aeaaa
Route
TOPICAL
Published
Effective Date 2021-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (725 mg) Iodine (8.3 mg)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Polyethylene Glycol, Unspecified Water Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-09

Description

Drug Facts

Purpose

Antiseptic Antiseptic


Medication Information

Purpose

Antiseptic Antiseptic

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Purposes

Antiseptic

Antiseptic

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
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.
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
Questions?

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

Other Information
  • store between 15-30 °C (59-86 °F)
  • avoid excessive heat above 40 °C (104 °F)
Inactive Ingredients

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

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 If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Bd Purprep™ 26 Ml Applicator

Isopropyl Alcohol 72.5% w/w

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Bd Purprep™ 10.5 Ml Applicator

Isopropyl Alcohol 7.2% w/w

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

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

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

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


Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Purposes

Antiseptic

Antiseptic

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
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.
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
Questions?

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

Other Information (Other information)
  • store between 15-30 °C (59-86 °F)
  • avoid excessive heat above 40 °C (104 °F)
Inactive Ingredients (Inactive ingredients)

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

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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Bd Purprep™ 26 Ml Applicator (BD PurPrep™ 26 mL Applicator)

Isopropyl Alcohol 72.5% w/w

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

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.

Bd Purprep™ 10.5 Ml Applicator (BD PurPrep™ 10.5 mL Applicator)

Isopropyl Alcohol 7.2% w/w

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

Bd Purprep™ 26 Ml Applicator Package 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

Bd Purprep™ 10.5 Ml Applicator Carton 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

Bd Purprep™ 10.5 Ml Applicator Package Label (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


Advanced Ingredient Data


Raw Label Data

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