Your browser does not support JavaScript! PREVAIL-FX ONE STEP (POVIDONE-IODINE AND ISOPROPYL ALCOHOL) SOLUTION [PRODUCTOS UROLOGOS DE MEXICO, S.A. DE C.V.]
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PREVAIL-FX ONE STEP (povidone-iodine and isopropyl alcohol) solution
[Productos Urologos de Mexico, S.A. de C.V.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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

Container Label

Container Label

PREVAIL-FX ONE STEP 
povidone-iodine and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57613-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE83 mg  in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL725 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A 
AMINOMETHYLPROPANOL 
POLYETHYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57613-009-401 in 1 POUCH
140 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/1998
Labeler - Productos Urologos de Mexico, S.A. de C.V. (812552219)
Establishment
NameAddressID/FEIBusiness Operations
Productos Urologos de Mexico, S.A. de C.V.812552219PACK, LABEL

Revised: 6/2010
 
Productos Urologos de Mexico, S.A. de C.V.

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