FDA.reportPublic FDA data

AMSure

Manufacturer
Amsino International, Inc.
Effective date
2012-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:31:15

Label at a glance#

ProductAMSure Alcohol Prep
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

Use For preparation of Skin prior to an injection.

Dosage and administration

Directions Wipe injection site vigorously and discard

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient

Isopropyl Alcohol 70%

Purpose Section

OTC - PURPOSE SECTION

Purpose

Antiseptic Cleanser

Keep Out Of Reach Of Children Section

OTC - 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

INDICATIONS & USAGE 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

DOSAGE & ADMINISTRATION SECTION

Directions

Wipe injection site vigorously and discard

Other Information Section

STORAGE AND HANDLING 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

TEAR HERE

Amsino AMSure Alcohol LabelAmsino AMSure Alcohol Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN2
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD2
797544isopropyl alcohol 70 % Medicated PadSY2
797544isopropyl alcohol 70 % Topical ClothSY2
797544isopropyl alcohol 70 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67752-0001-12020-01-31C16284748780-19d75b9d1-0a77-f424-e053-dadaa90a57ce5496aba5-f35b-46cc-bda9-5a89e30bb52a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67752-0001-1AMSureAlcohol Prep0.4 mL in 1 POUCHSWAB0.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67752-0001AMSURE ALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [AMSINO INTERNATIONAL, INC.]2Legacy NDC, 1 package rows20120328_5496aba5-f35b-46cc-bda9-5a89e30bb52a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163022
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163022
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67752-000167752-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
928c5bfc-70bc-4ff6-a6db-7b404538ec795496aba5-f35b-46cc-bda9-5a89e30bb52a2012-03-27WarningsExact identifier
spl id: 928c5bfc-70bc-4ff6-a6db-7b404538ec79
spl set id: 5496aba5-f35b-46cc-bda9-5a89e30bb52a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.