FDA.reportPublic FDA data

Isopropyl Alcohol 91 Percent

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:33

Label at a glance#

ProductIsopropyl Alcohol 91 Percent
Active ingredientISOPROPYL ALCOHOL
Label structure15 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 91% by volume

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Use

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of infection in.

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only.

  • Flammable, keep way from spark, heat and flame.

Ask a doctor before use for

OTC - ASK DOCTOR SECTION

  • deep wounds
  • animal bites
  • 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 1 week

Stop use and ask a doctor if

OTC - STOP USE SECTION

If condition persists or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

OTHER SAFETY INFORMATION

  • store at controlled 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 Ingredient

INACTIVE INGREDIENT SECTION

purified water

Good Neighbor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPGNP

Health Mart Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HM91.jpgHM91.jpgHMHM

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SM91.jpgSM91.jpgSMSM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN2
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD2
582901isopropyl alcohol 91 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-914-16Isopropyl Alcohol 91 Percent473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-914ISOPROPYL ALCOHOL 91 PERCENT (ISOPROPYL ALCOHOL) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231223_e42f6c6d-c4e0-02c6-e053-2995a90a3ace.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
82645-91482645-914-16

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
Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e0-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
ndc (package): 82645-914-16
ndc (product): 82645-914
ndc11 (package): 82645091416
spl id: 0d1cfe14-52e7-8975-e063-6294a90afbb7
spl set id: e42f6c6d-c4e0-02c6-e053-2995a90a3ace

Reported adverse events (FAERS/openFDA)#

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