FDA.reportPublic FDA data

TopCo

Manufacturer
Topco Associates | Medline Industries, LP
Effective date
2023-08-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:27:05

Label at a glance#

ProductTopCo
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

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

OTHER SAFETY INFORMATION

  • • protect from freezing and avoid excessive heat
  • • not made with natural rubber latex

Inactive ingredients

INACTIVE INGREDIENT SECTION

water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Distributed by:

Topco Associates LLC.

150 NW Point Blvd, Elk Grove Village, IL 60007 USA

1-888-423-0139

topcare@topco.com

Made in China

TOP45581V1

RJ18SXM

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

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
76162-81076162-810-86

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
03708e08-0188-b83d-e063-6394a90a50e6be641465-3740-1b05-e053-2a95a90a3b402023-08-21WarningsExact identifier
spl id: 03708e08-0188-b83d-e063-6394a90a50e6
spl set id: be641465-3740-1b05-e053-2a95a90a3b40

Reported adverse events (FAERS/openFDA)#

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