FDA.reportPublic FDA data

I.V. Prep Antiseptic Wipe Sterile Solution

Manufacturer
Smith & Nephew, Medical Ltd | Span Packaging Solutions
Effective date
2024-03-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:13:18

Label at a glance#

ProductI.V. Prep Antiseptic Wipe
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Indications and uses

For preparation of skin prior to injection or venipuncture

Dosage and administration

clean the area start at the venipuncture site and apply in a circular fashion using friction Let dry and repeat procedure Allow I.V. PREP to dry prior to application of dressings

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (IN EACH PACKET)

OTC - ACTIVE INGREDIENT SECTION

 Isopropyl Alcohol 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USES

INDICATIONS & USAGE SECTION

For preparation of skin prior to injection or venipuncture

WARNINGS

WARNINGS SECTION

  • FLAMMABLEUse in a well-ventilated area and avoid using near flames or sources of ignition i.e. electrocautery procedures
  • Sterile. Do not useif pack is open or damaged
  • For external use only.Do not usein or near the eyes
  • Discontinue useif irritation or redness develop. If condition persistsmore than 72 hours, consult a physician
  • Limit exposure only to the immediate application site. Avoid use on children less than 12 years old as it may lead to irritation

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poisin Control Center immediately

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • clean the area
  • start at the venipuncture site and apply in a circular fashion using friction
  • Let dry and repeat procedure
  • Allow I.V. PREP to dry prior to application of dressings

CONTRAINDICATION

CONTRAINDICATIONS SECTION

Should not be used on full-term or premature babies less than 1 month

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

acetyl tributyl citrate, butyl ester of PVM/MA copolymer, benzalkonium chloride, water

OTC - QUESTIONS SECTION

Made in the USA for Smith & Nephew Medical Ltd

101 Hessle Road, Hull, HU3 2BN, England

Customer Care Center: 1 800 876-1261

www.smith-nephew.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- BOX OF 50 WIPES (Front)

#59421200

NDC 69740-212-00

I.V. PREP

(isopropyl alcohol, 70%)

Antiseptic Wipes

Sterile Solution

  • For preparation of the skin prior to injection or venipuncture

50 Wipes

50 wipes50 wipes

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- 1 Packet

#59421200

NDC 69740-212-00

I.V. PREP

(isopropyl alcohol, 70%)

Antiseptic Wipe

Sterile Solution

  •  For preparation of the skin prior to injection or venipuncture

1 Wipe

 Made in the USA for Smith & Nephew Medical Ltd

101 Hessle Road, Hull, HU3 2BN, England

Customer Care Center: 1 800 876-1261

www.smith-nephew.com

1 Wipe1 Wipe

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN8
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD8
797544isopropyl alcohol 70 % Medicated PadSY8
797544isopropyl alcohol 70 % Topical ClothSY8
797544isopropyl alcohol 70 % Topical SwabSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-212-002024-06-04C16284748780-1f386c649-b42a-0266-e053-dadaa90a7c1aI.V. Prep Antiseptic Wipe Sterile Solution
69740-212-002023-01-30C16284748780-1f386c649-b42a-0266-e053-dadaa90a7c1aI.V. Prep Antiseptic Wipe Sterile Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-212-00I.V. Prep Antiseptic Wipe50 in 1 BOXCLOTH508
69740-212-00I.V. Prep Antiseptic Wipe3.7 mL in 1 POUCHCLOTH3.78

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-212I.V. PREP ANTISEPTIC WIPE (ISOPROPYL ALCOHOL) CLOTH [SMITH & NEPHEW, MEDICAL LTD]8Current NDC, Legacy NDC, 2 package rows20240605_50f1c74a-bb8e-41c2-a7ee-f2d310a372a7.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69740-21269740-212-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETYLTRIBUTYL CITRATE0ZBX0N59RZIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML

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
I.V. Prep Antiseptic WipeISOPROPYL ALCOHOLSmith & Nephew, Medical Ltd50f1c74a-bb8e-41c2-a7ee-f2d310a372a72024-03-21WarningsExact identifier
ndc (package): 69740-212-00
ndc (product): 69740-212
ndc11 (package): 69740021200
spl id: 143483a1-294e-017e-e063-6294a90a0456
spl set id: 50f1c74a-bb8e-41c2-a7ee-f2d310a372a7

Reported adverse events (FAERS/openFDA)#

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