Prevail® One-Step Gel and Applicator

Manufacturer
CareFusion 2200 Inc
Effective date
2019-12-10
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 23:54:15

Label at a glance#

ProductPrevail One Step
Active ingredientpovidone-iodine, alcohol
Label structure9 sections

Dosage and administration

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 solutio...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Ethanol 62% (v/v)

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

PURPOSES

OTC - PURPOSE SECTION

Antiseptic

Antiseptic

USE

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

use in well ventilated area.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Store at USP room temperature, 20-25°C (66-77°F)
  • Avoid excessive heat (not to exceed 104°F/40°C)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4VAIL4VAIL

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:

  • 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 do dry.
  • do not allow solution to pool.
  • remove wet material from prep area.

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M6
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M6
ALCOHOLACTIVE MOIETY3K9958V90M6
IODINEACTIVE MOIETY9679TC07X46
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP6
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671P6
NONOXYNOL-10INACTIVE INGREDIENTK7O76887AP6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57613-00857613-008-59

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 364 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR7.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, CHEWABLE / ORAL10 mgExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION, AUGMENTED / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, COATED PELLETS / ORAL41.4 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii candidate
27 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PFILM / BUCCAL87 mgExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBCUTANEOUS1 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PPOWDER, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
27 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSNAExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE / ORAL60 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a4da2a32-9713-4399-9e94-b8ff602dc818f2de3d0e-4887-41b2-9648-568979bb5cc12019-12-10WarningsExact identifier
spl id: a4da2a32-9713-4399-9e94-b8ff602dc818
spl set id: f2de3d0e-4887-41b2-9648-568979bb5cc1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.