PREVAIL-FX ONE STEP- povidone-iodine and isopropyl alcohol solution

Prevail-FX One Step by

Drug Labeling and Warnings

Prevail-FX One Step by is a Otc medication manufactured, distributed, or labeled by CareFusion 2200 Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Isopropyl Alcohol 72.5% (w/w)

Povidone-iodine USP 8.3% (0.83% available iodine)

PURPOSE

Antiseptic

Antiseptic

USES

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

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.
• 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).
• 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.
• Remove wet materials from prep area.
• If prep accidentally drips into hair, allow to dry completely.

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 iodine sensitive patients.
• on open skin wounds or as a general skin cleanser.
• in the eyes or for prepping mucous membranes.

When using this product

use in well ventilated area.

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.

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

Directions

• to reduce the risk of fire the following strategies are recommended:
  • at the end of 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.
• Hold the bottle in an upright position.
• Twist the applicator head in the direction of the arrow until it stops.
• Firmly push the applicator head down into the bottle until a snap is heard.
• Invert bottle and gently squeeze to dispense solution.
• Once applicator sponge has been primed with solution, do not continue to squeeze the bottle
• When applicable, press cotton-tipped swab securely against impregnated applicator head to wet, then clean umbilicus.
• Apply thin, even coat to operative site. Do not blot.
• If applying prep to a tight area (e.g., neck, skin folds), insert prep towels underneath to absorb excess solution.
• Remove any excess prep with absorbent towels or gauze.
• Discard prepping materials, including solution soaked materials.
• Wait until prep is dry (3 minutes or more) on skin before draping or using ignition sources.
• Remove with high pH-level soap and water.

Other Information

• Store at USP room temperature, 20-25°C (66-77°F)
• Avoid excessive heat (not to exceed 104°F (40°C)

Inactive Ingredients

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

Questions?

call: 1-800-523-0502 (M-F 8 AM-5PM CST)

PRINCIPAL DISPLAY PANEL

Cat. 4VAIL-FX

NDC: 57613-009-40

Prevail-FX ® One Step Solution and Applicator

Topical Patient Preoperative Skin Prep

Non-sterile Solution

Applicator is sterile if package is intact

Povidone-iodine USP 8.3% (0.83% Available Iodine) with 72.5% Isopropyl Alcohol w/w 40ml

For Single Use Only

WARNING:

FLAMMABLE, keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

• solution contains alcohol and gives off flammable vapors
• 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).
• 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.
• remove wet material from prep area.

See insert before using this product.

1.4 fl oz

U.S. Patent Nos. 6,228,354 and 7,201,525.

51-10087

Manufactured for CareFusion, Vernon Hills, IL 60061 USA

INGREDIENTS AND APPEARANCE

PREVAIL-FX ONE STEP 
povidone-iodine and isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57613-009
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
Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)
Aminomethylpropanol (UNII: LU49E6626Q)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57613-009-40	1 in 1 POUCH	06/01/1998	04/30/2021
1		40 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	06/01/1998	04/30/2021

Labeler - CareFusion 2200 Inc (832696038)