Antiseptic
FDA Label NDC 52641-700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reliamed for the product Antiseptic (NDC 52641-700). 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 - do not use, otc - stop use, otc - keep out of reach of children, 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.

Otc - Do Not Use

Do not use with electrocautery procedures or in or near the eyes. For external use only.

Otc - Stop Use

Stop use and ask a 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

  • clean the area
  • start at the venipuncture site and apply in a circular fashion using friction

Inactive Ingredients

purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol SDA-40B, acetyl tributyl citrate, chloroxylenol

Principal Display Panel – Packet Label

REORDER NO. ZA50075

LATEX FREE

NDC 52641-700-02

ReliaMed

I.V.
Antiseptic Wipes

For preparation of the skin prior
to injection or venipuncture

Contains: One Wipe

Distributed by ReliaMed

Ft. Worth, TX 76106 1-800-409-2848

Made in the U.S.A. Rev 050611

TEAR HERE

Principal Display Panel – Packet Label (Rel00 0004 01)

Principal Display Panel – Packet Label (Rel00 0004 01)

Principal Display Panel – Box Label

NEW

ReliaMed

REORDER NO. ZA50075

LATEX FREE

NDC 52641-700-02

I.V. Antiseptic Wipes

For preparation of the skin prior to injection or venipuncture

75 Individual Wipes

  • Protect skin from adhesives
  • Non-irritating to intact skin
  • Thick, soft application pad
    Principal Display Panel – Box Label (Rel00 0004 02)

    Principal Display Panel – Box Label (Rel00 0004 02)

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