Prevail-FX® Drug Facts

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® Drug Facts

ACTIVE INGREDIENT

PVP-I, Isopropyl Alcohol 72.5% (w/w)

PURPOSE

Antiseptic

USES

For preparation of the patient’s skin prior to surgery.

WARNINGS

Do not use

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

Other Information

Inactive Ingredients

U.S. components assembled in Mexico except as indicated:

Cotton-Tipped Swabs Made in China

Cardinal Health
McGaw Park, IL 60085 USA

30-3061

U.S. Patent Nos. 5,916,882, 6,488,665 and 6,228,354.

PRINCIPAL DISPLAY PANEL

Principal Display Panel for Prevail FX

PREVAIL-FX ONE STEP 
povidone-iodine and isopropyl alcohol   solution
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)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
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
157613-009-401 APPLICATOR In 1 POUCHcontains a APPLICATOR
140 mL In 1 APPLICATORThis package is contained within the POUCH (57613-009-40)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33306/01/1998

Labeler - Productos Urologos de Mexico, S.A. de C.V. (812552219)
Establishment
NameAddressID/FEIOperations
Productos Urologos de Mexico, S.A. de C.V.812552219PACK, LABEL
Revised: 11/2009Productos Urologos de Mexico, S.A. de C.V.