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

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:

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 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 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 it is not necessary to 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
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 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

Citric Acid
Glycerin
Hydroxypropylcellulose
Nonoxynol-10
Simethicone
Sodium Hydroxide
USP purified water

Questions?

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

PRINCIPAL DISPLAY PANEL

Principal display panel

Label

PREVAIL ONE STEP 
povidone-iodine and alcohol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57613-008
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE5 mg  in 1 mL
ALCOHOL (ALCOHOL) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
HYDROXYPROPYL CELLULOSE (TYPE H) 
SODIUM HYDROXIDE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
NONOXYNOL-10 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57613-008-591 in 1 POUCH
159 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/1997
Labeler - Productos Urologos de Mexico, S.A. de C.V. (812552219)
Registrant - CareFusion 213 LLC (826496312)
Establishment
NameAddressID/FEIBusiness Operations
Productos Urologos de Mexico, S.A. de C.V.812552219LABEL(57613-008), PACK(57613-008)

Revised: 12/2012
Document Id: 0398dad8-568e-4218-a873-b9d37764d52b
Set id: f2de3d0e-4887-41b2-9648-568979bb5cc1
Version: 6
Effective Time: 20121221
 
Productos Urologos de Mexico, S.A. de C.V.