Alcohol Prep
FDA Label NDC 0924-0011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Alcohol Prep (NDC 0924-0011). 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 otc - active ingredient, purpose, warnings:, indications and usage:, keep out of reach of children., directions:, other information:, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic


Purpose

For preparation of the skin prior to injection.

Warnings:

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes
  • Sterile unless package is damaged or open.

Indications And Usage:

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Wipe injection site vigorously and discard

Other Information:

  • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

Inactive Ingredient

  • Water

Principal Display Panel - Box

PRINCIPAL DISPLAY PANEL - 100 count box

PAK-KIT FIRST AID

STERILE ALCOHOL PREP PADS

Contains 100 single use alcohol prep pads.

See back panel for Drug Facts listing.

Distributed by: Acme United Corporation

Fairfield, CT 06824   800-835-2263

PK alcohol prep B.jpg

Principal Display Panel - Packet

PRINCIPAL DISPLAY PANEL - packet

Dynarex Alcohol Prep Pad

STERILE ALCOHOL PREP PADS


Contains 1 single use alcohol prep pads.

Acme United Corporation 

Fairfield, CT 06824

PK alcohol prep P.jpg

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