FDA.reportPublic FDA data

Alcohol Prep

Manufacturer
Topco Associates
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:05:48

Label at a glance#

ProductAlcohol Prep
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

First aid to decrease germs in minor cuts, scrapes and burns.

Dosage and administration

Apply to skin as needed Discard after single use

Storage and handling

Protect from freezing and avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol, 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • First aid to decrease germs in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

  • For external use only.
  • Flammable. Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • with electrocautery procedures
  • longer than 1 week unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not apply over large areas of the body
  • in case of deep or puncture wounds, animal bites or serious burns, consult a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition gets worse or persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to skin as needed
  • Discard after single use

Other information

STORAGE AND HANDLING SECTION

Protect from freezing and avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Distributed By:

Topco Associates LLC.

Elk Grove Village, IL 60007

©TopCo MDLA0618

Questions? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

Made in China

RD20LPD

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN7
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD7
797544isopropyl alcohol 70 % Medicated PadSY7
797544isopropyl alcohol 70 % Topical ClothSY7
797544isopropyl alcohol 70 % Topical SwabSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76162-809-302021-01-15C16284748780-19d75b9cf-e3f0-f424-e053-dadaa90a57ce76162-809 Top Care IPA Pads
76162-809-302020-01-31C16284748780-19d75b9cf-e3f0-f424-e053-dadaa90a57ce76162-809 Top Care IPA Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-809-30Alcohol Prep1 in 1 PACKETSWAB17
76162-809-30Alcohol Prep100 in 1 BOXSWAB1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-809ALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [TOPCO ASSOCIATES]7Current NDC, Legacy NDC, 2 package rows20231228_65270825-48b1-49e7-a14e-f73df9beb9dd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163023
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163023
WATERINACTIVE INGREDIENT059QF0KO0R3

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
76162-80976162-809-30

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
Alcohol PrepISOPROPYL ALCOHOLTopco Associates65270825-48b1-49e7-a14e-f73df9beb9dd2023-12-27WarningsExact identifier
ndc (package): 76162-809-30
ndc (product): 76162-809
ndc11 (package): 76162080930
spl id: 0d7ffc64-5322-ba5d-e063-6294a90a6cac
spl set id: 65270825-48b1-49e7-a14e-f73df9beb9dd

Reported adverse events (FAERS/openFDA)#

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