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 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 (IODINE) POVIDONE-IODINE 83 mg  in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 725 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57613-009-40 1 APPLICATOR In 1 POUCH contains a APPLICATOR
1 40 mL In 1 APPLICATOR This package is contained within the POUCH (57613-009-40)

Marketing Information
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. (812552219)
Establishment
Name Address ID/FEI Operations
Productos Urologos de Mexico, S.A. de C.V. 812552219 PACK, LABEL
Revised: 11/2009 Productos Urologos de Mexico, S.A. de C.V.