Prevail-FX® Drug Facts
PREVAIL-FX ONE STEP
isopropyl alcohol solution
Productos Urologos de Mexico, S.A. de C.V.
Prevail-FX® Drug Facts
PVP-I, Isopropyl Alcohol 72.5% (w/w)
For preparation of the patient’s skin prior to surgery.
- Solution is flammable until dry. Keep away from fire or flame
- Do not drape or use ignition source until dry (e.g., electrocautery / laser)
- Do not allow to pool
- Remove all solution soaked materials
For external use only
- 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
- On iodine sensitive patients
- On open skin wounds or as a general skin cleanser
- Not for ophthalmic use, 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.
- Grasp the bottle with one hand. With the other hand, grasp the applicator neck. Make sure the applicator is pointing up
- Slowly twist the applicator neck in the direction of the arrow until it stops
- Push the applicator into the bottle to activate
- Invert bottle and squeeze to dispense solution
- Press cotton-tipped swab securely against impregnated applicator head to wet
- When applicable, 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 (2-3 minutes) on skin before draping or using ignition sources
- Remove with high pH-level soap and water
- Store at room temperature
- Avoid excessive heat (not to exceed 104 °F / 40 °C)
- USP purified water, copolymer
U.S. components assembled in Mexico except as indicated:
Cotton-Tipped Swabs Made in China
McGaw Park, IL 60085 USA
U.S. Patent Nos. 5,916,882, 6,488,665 and 6,228,354.
PRINCIPAL DISPLAY PANEL
|PREVAIL-FX ONE STEP
povidone-iodine and isopropyl alcohol
|Product Type||HUMAN OTC DRUG||NDC Product Code (Source)||57613-009
|Route of Administration||TOPICAL||DEA Schedule||
|Active Ingredient/Active Moiety
|Ingredient Name||Basis of Strength||Strength
||POVIDONE-IODINE||83 mg in 1 mL
||ISOPROPYL ALCOHOL||725 mg in 1 mL
|#||NDC||Package Description||Multilevel Packaging
POUCH||contains a APPLICATOR
APPLICATOR||This package is contained within the POUCH (57613-009-40)
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date
|OTC monograph not final||part333||06/01/1998||
|Labeler - Productos Urologos de Mexico, S.A. de C.V.
Revised: 11/2009Productos Urologos de Mexico, S.A. de C.V.
|Productos Urologos de Mexico, S.A. de C.V.||812552219||PACK, LABEL