PREVAIL ONE STEP- povidone-iodine and alcohol gel 
Productos Urologos de Mexico, S.A. de C.V.

Disclaimer: 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.

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Prevail® One-Step Gel and Applicator

ACTIVE INGREDIENTS

Ethanol 62% (v/v)

Povidone-iodine USP 5.0% (0.5% available iodine)

PURPOSES

Antiseptic

Antiseptic

USE

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

WARNINGS

For external use only.

Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY:

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

OTHER INFORMATION

INACTIVE INGREDIENTS

Questions?

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

PRINCIPAL DISPLAY PANEL

4VAIL

Cat. 4VAIL

NDC 57613-008-59

Prevail ® One Step Gel and Applicator

Topical Patient Preoperative Skin Prep

Non-sterile Solution

Applicator is sterile if package is intact

Povidone-iodine USP 5% (0.5% Available Iodine) with 62% Ethanol (v/v) 59ml

For Single Use Only

WARNING:

FLAMMABLE, keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

See insert before using this product.

2 fl oz

U.S. Patent Nos. 5,916,882, 6,488,665 and 7,201,525.

51-10086

Manufactured for CareFusion, Vernon Hills, IL 60061 USA

PREVAIL ONE STEP 
povidone-iodine and alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57613-008
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 5 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-10 (UNII: K7O76887AP)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57613-008-59 1 in 1 POUCH 06/01/1997
1 59 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 06/01/1997
Labeler - Productos Urologos de Mexico, S.A. de C.V. (812552219)
Registrant - CareFusion 2200. Inc. (832696038)
Establishment
Name Address ID/FEI Business Operations
Productos Urologos de Mexico, S.A. de C.V. 812552219 label(57613-008) , pack(57613-008)

Revised: 10/2016
Document Id: 3e22ac9a-724b-3ba0-e054-00144ff88e88
Set id: f2de3d0e-4887-41b2-9648-568979bb5cc1
Version: 8
Effective Time: 20161005
 
Productos Urologos de Mexico, S.A. de C.V.