FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-11
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:43:59

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure16 sections

Indications and uses

first aid to help prevent the risk of infection in: minor cuts scrapes burns

Dosage and administration

clean the affected area apply a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only. If taken internally serious gastric disturbances will result.

Flammable

SPL UNCLASSIFIED SECTION

  • keep away from fire or flame, heat, spark, electrical
  • do not use as a fuel source. If exposed to a heat source, vapors may ignite, resulting in severe burns, serious injury, or death.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

for deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not inhale
  • do not apply over large areas of the body
  • do not use longer than 1 week
  • use only as directed

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Caution

WARNINGS AND PRECAUTIONS SECTION

Fumes can be acutely irritating to skin, eyes and the respiratory system.  Do not apply to irritated skin or if excessive irritation develops. Avoid gettting into the eyes or on mucous membranes.  Avoid inhaling this product.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

SPL UNCLASSIFIED SECTION

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredients

INACTIVE INGREDIENT SECTION

blue 1, glycerin, methyl salicylate, water, yellow 5

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO

Questions? 1-888-423-0139 topcare@topco.com www.topcarebrand.com

Visit here for more information: topbrnds.com Quality Guaranteed

Pat. D675, 101

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®

health

70% Isopropyl Alcohol

First Aid Antiseptic

With Wintergreen & Glycerin

  • Use for Body Rub & Massage
  • Decreases Germs in Minor Cuts & Scrapes

WINTERGREEN

WARNING FLAMMABLE 

  • Keep away from heat, spark, electrical, fire or flame
  • DANGER: DO NOT USE AS A FUEL SOURCE

If exposed to a heat source, vapors may ignite, resulting in severe burns, serious injury, or death.

CAUTION: Do not point at self or others: product will squirt when squeezed.

Use only as directed, in a well- ventiliated area: fumes can be harmful.

16 FL OZ (1 PT) 473 mL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN11
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD11
808520isopropyl alcohol 70 % Topical SolutionSY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0012443BCmm02.jpg
Data codeData MatrixL0012443FCmm01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-845-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID47311

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-84576162-845-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
METHYL SALICYLATELAV5U5022YIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCbe4f41bd-8a75-4fb6-8d28-67f6f853e6bd2026-02-11Warnings, Adverse reactionsExact identifier
ndc (package): 76162-845-43
ndc (product): 76162-845
ndc11 (package): 76162084543
spl id: 4a91d6ff-3c8b-ca66-e063-6294a90a576e
spl set id: be4f41bd-8a75-4fb6-8d28-67f6f853e6bd

Reported adverse events (FAERS/openFDA)#

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