FDA Label for Purprep
View Indications, Usage & Precautions
Purprep Product Label
The following document was submitted to the FDA by the labeler of this product Carefusion 213 Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Isopropyl alcohol 72.5% w/w
Povidone-iodine 8.3% w/w (0.83% available iodine)
Otc - 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
Otc - 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
Otc - When Using
When using this product use in well ventilated area.
Otc - Stop Use
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These maybe signs of a serious condition.
Otc - 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
Otc - Questions
Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
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