Antiseptic
FDA Label NDC 61010-7000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America for the product Antiseptic (NDC 61010-7000). 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 other, active ingredients, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Isopropyl Alcohol 71.5%

Purpose

Antiseptic

Uses

  • For preparation of the skin prior to injection or venipuncture

Warnings

For external use only

Flammable. Keep away from fire or flame

Do not use with electrocautery procedures or in or near the eyes. If this happens, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

Directions

  • start at the venipuncture site and apply in a circular fashion
  • use additional wipes as necessary to cover area

Inactive Ingredients

purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol, acetyl tributyl citrate, chloroxylenol

Principal Display Panel – Packet Label

Safetec

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

Principal Display Panel – Packet Label (Iso01 0003 01)

Principal Display Panel – Packet Label (Iso01 0003 01)

Principal Display Panel – Box

Safetec

Contents: 50 individual, single-use, premoistened towelettes

NDC 61010-7000-1

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture

Principal Display Panel – Box (Iso01 0003 02)

Principal Display Panel – Box (Iso01 0003 02)

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