I.v. Prep Antiseptic Wipe Cloth
FDA Label NDC 69740-212

7 label sections · Submitted to the FDA by Smith & Nephew, Medical Ltd · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smith & Nephew, Medical Ltd for the product I.v. Prep Antiseptic Wipe (NDC 69740-212). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each packet), purpose, uses, warnings, directions, contraindication, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Packet)

 Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

For preparation of skin prior to injection or venipuncture

Warnings

  • 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

Directions

  • 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

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

Inactive Ingredients

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

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