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

Purpose

Antiseptic Antiseptic

Description

Drug Facts


Medication Information

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
Purpose

Antiseptic Antiseptic

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.
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

Description

Drug Facts

Questions?

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

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

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
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

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.
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

Questions?

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

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

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
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


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