FDA.reportPublic FDA data

Isopropyl Alcohol 99%

Manufacturer
UBQ Industries, LLC
Effective date
2021-11-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:04

Label at a glance#

ProductIsopropyl Alcohol 99%
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

store at room temperature. does not contain, nor is intended as a substitute for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 99% v/v. Purpose: Antiseptic

Purpose Section

OTC - PURPOSE SECTION

first aid antiseptic, isopropyl alcohol

Indications and usage section

INDICATIONS & USAGE SECTION

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

Warnings Section

For external use only. Flammable. Keep away from heat or flame

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes, do not apply over large areas of the body, do not use longer than one week unless directed by a doctor

Stop using this product if

OTC - STOP USE SECTION

condition persists or gets worse

Keep this and all drugs our of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidentail ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

store at room temperature. does not contain, nor is intended as a substitute for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ml NDC 80668-414-05
236 ml - IPA236 ml - IPA

946.4 ml NDC 80668-414-06
946.4 ml - IPA946.4 ml - IPA

18927 ml NDC 80668-414-01
ipa-5gipa-5g

3785 ml NDC 80668-414-02
ipa-128ipa-128

1892 ml NDC 80668-414-03
ipa-64ipa-64

IPA-16IPA-16473.2ml NDC 80668-414-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
402481isopropyl alcohol 99 % Topical SolutionPSN3
402481isopropyl alcohol 0.99 ML/ML Topical SolutionSCD3
402481isopropyl alcohol 99 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80668-414-012023-01-30C16284748780-1f386c649-cbf1-0266-e053-dadaa90a7c1aIsopropyl Alcohol 99%
80668-414-022023-01-30C16284748780-1f386c649-cbf1-0266-e053-dadaa90a7c1aIsopropyl Alcohol 99%
80668-414-032023-01-30C16284748780-1f386c649-cbf1-0266-e053-dadaa90a7c1aIsopropyl Alcohol 99%
80668-414-042023-01-30C16284748780-1f386c649-cbf1-0266-e053-dadaa90a7c1aIsopropyl Alcohol 99%
80668-414-052023-01-30C16284748780-1f386c649-cbf1-0266-e053-dadaa90a7c1aIsopropyl Alcohol 99%
80668-414-062023-01-30C16284748780-1f386c649-cbf1-0266-e053-dadaa90a7c1aIsopropyl Alcohol 99%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80668-414-01Isopropyl Alcohol 99%18927 mL in 1 PAILLIQUID189273
80668-414-02Isopropyl Alcohol 99%3785 mL in 1 BOTTLE, PLASTICLIQUID37853
80668-414-03Isopropyl Alcohol 99%1892 mL in 1 BOTTLE, PLASTICLIQUID18923
80668-414-04Isopropyl Alcohol 99%473.2 mL in 1 BOTTLE, PLASTICLIQUID473.23
80668-414-05Isopropyl Alcohol 99%236 mL in 1 BOTTLELIQUID2363
80668-414-06Isopropyl Alcohol 99%946.4 mL in 1 JUGLIQUID946.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80668-414ISOPROPYL ALCOHOL 99% LIQUID [UBQ INDUSTRIES, LLC]3Legacy NDC, 6 package rows20211124_b56cfda8-459c-5691-e053-2995a90a5a31.zip

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
80668-41480668-414-01, 80668-414-02, 80668-414-03, 80668-414-04, 80668-414-06, 80668-414-05

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
d179108c-c470-8691-e053-2a95a90ace7ab56cfda8-459c-5691-e053-2995a90a5a312021-11-23WarningsExact identifier
spl id: d179108c-c470-8691-e053-2a95a90ace7a
spl set id: b56cfda8-459c-5691-e053-2995a90a5a31

Reported adverse events (FAERS/openFDA)#

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