Amsure
FDA Label NDC 67752-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amsino International, Inc. for the product Amsure (NDC 67752-0001). 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 ingredient section, purpose section, keep out of reach of children section, uses section, warnings section, directions section, other information section, inactive ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient Section

Drug Facts

Active ingredient

Isopropyl Alcohol 70%

Purpose Section

Purpose

Antiseptic Cleanser

Keep Out Of Reach Of Children Section

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

Uses Section

Use For preparation of Skin prior to an injection.

Warnings Section

Warnings

  • For External Use Only
  • Flammable, Keep away from fire or flame
  • Do Not Use 1) with electrocautery procedures 2) In the eyes. If contact occurs, flush eyes with water
  • Stop Use If irritation and redness develop. If condition persists, contact your health care practitioner.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions Section

Directions

Wipe injection site vigorously and discard

Other Information Section

Other information

Store at room temperature: 15 degrees C - 30 degrees C (59-86 degrees F)

Inactive Ingredient Section

Inactive ingredients

purified water

Package Label

NDC 67752-0001-1   AMSINO   AMSure Alcohol Prep Pad  Prep pad size 1-1/5"x1-1/5"   REF APP001S

STERILE   DO NOT REUSE   LATEX FREE

Distributed by: Amsino International, Inc.   855 Towne Center Dr., Pomona, CA 91767, USA

AMSure is a registered trademark of Amisino International, Inc.   L5666 Rev. A

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Amsino Amsure Alcohol Label (Amsino Amsure Alcohol1)

Amsino Amsure Alcohol Label (Amsino Amsure Alcohol1)

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