PURPREP- povidone iodine and isopropyl alcohol sponge

PurPrep by

Drug Labeling and Warnings

PurPrep by is a Otc medication manufactured, distributed, or labeled by CareFusion 213 LLC, Becton, Dickinson and Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Isopropyl alcohol 72.5% w/w

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

PURPOSE

Antiseptic

Antiseptic

INDICATIONS & USAGE

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

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

WHEN USING

When using this product use in well ventilated area.

STOP USE

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These maybe signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• to reduce risk of fire the following strategies are recommended:
  • at the end of the prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available.
  • use in a well ventilated area
  • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
  • do not allow solution to pool; tuck prep towels to absorb solution, and then remove.
  • remove wet materials from prep area
  • drape after solution is completely dry
  • do not use 26 mL applicator for head and neck surgery
  • 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
  • apply thin, even coat to operative site. Do not blot.
  • discard prepping materials, including solution soaked materials.
  • wait until prep is dry (3 minutes or more) on skin before draping or using ignition sources

OTHER SAFETY INFORMATION

• store between 15-30 o C (59-86 o F)
• avoid excessive heat above 40 o C (104 o F)

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURPREP 
povidone iodine and isopropyl alcohol sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54365-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	8.3 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	725 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54365-014-42	1 in 1 POUCH	04/09/2020
1		26 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/09/2020

Labeler - CareFusion 213 LLC (826496312)

Registrant - CareFusion 2200 LLC (832696038)

Establishment
Name	Address	ID/FEI	Business Operations
Becton, Dickinson and Company		124987988	manufacture(54365-014)

Establishment
Name	Address	ID/FEI	Business Operations
CareFusion 213 LLC		826496312	manufacture(54365-014) , pack(54365-014) , label(54365-014)