FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol 99%

Manufacturer
First Aid Research Corp. | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:22

Label at a glance#

ProductIsopropyl Rubbing Alcohol 99%
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (by volume)

Isopropyl Alcohol (99%)

OTC - PURPOSE SECTION

Purpose

First Aid Antiseptic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

  • Flammable, keep away from fire and flame
  • if taken internally, serious gastric disturbances will result

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

When using this product

  • 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
  • do not use otherwise than directed

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of ingestion, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredient

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 99%
FIRST AID ANTISEPTIC
12 FL.OZ (355 mL)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
402481isopropyl alcohol 99 % Topical SolutionPSN1
402481isopropyl alcohol 0.99 ML/ML Topical SolutionSCD1
402481isopropyl alcohol 99 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75983-007-012022-01-28C16284748780-1d6a99b39-5a77-a426-e053-dadaa90af4c2Isopropyl Rubbing Alcohol 99%
75983-007-022022-01-28C16284748780-1d6a99b39-5a77-a426-e053-dadaa90af4c2Isopropyl Rubbing Alcohol 99%
75983-007-032022-01-28C16284748780-1d6a99b39-5a77-a426-e053-dadaa90af4c2Isopropyl Rubbing Alcohol 99%
75983-007-042022-01-28C16284748780-1d6a99b39-5a77-a426-e053-dadaa90af4c2Isopropyl Rubbing Alcohol 99%
75983-007-052022-01-28C16284748780-1d6a99b39-5a77-a426-e053-dadaa90af4c2Isopropyl Rubbing Alcohol 99%
75983-007-062022-01-28C16284748780-1d6a99b39-5a77-a426-e053-dadaa90af4c2Isopropyl Rubbing Alcohol 99%
75983-007-072022-01-28C16284748780-1d6a99b39-5a77-a426-e053-dadaa90af4c2Isopropyl Rubbing Alcohol 99%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75983-007-01Isopropyl Rubbing Alcohol 99%118 mL in 1 BOTTLE, PLASTICLIQUID1181
75983-007-02Isopropyl Rubbing Alcohol 99%177 mL in 1 BOTTLE, PLASTICLIQUID1771
75983-007-03Isopropyl Rubbing Alcohol 99%237 mL in 1 BOTTLE, PLASTICLIQUID2371
75983-007-04Isopropyl Rubbing Alcohol 99%296 mL in 1 BOTTLE, PLASTICLIQUID2961
75983-007-05Isopropyl Rubbing Alcohol 99%355 mL in 1 BOTTLE, PLASTICLIQUID3551
75983-007-06Isopropyl Rubbing Alcohol 99%414 mL in 1 BOTTLE, PLASTICLIQUID4141
75983-007-07Isopropyl Rubbing Alcohol 99%473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75983-007ISOPROPYL RUBBING ALCOHOL 99% (ISOPROPYL ALCOHOL) LIQUID [FIRST AID RESEARCH CORP.]1Legacy NDC, 7 package rows20200613_1ad2248f-e0fa-4618-a9b3-8fb35eb7d28c.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
75983-00775983-007-01, 75983-007-02, 75983-007-03, 75983-007-04, 75983-007-05, 75983-007-06, 75983-007-07

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
a7bd439f-181e-9479-e053-2995a90aeb511ad2248f-e0fa-4618-a9b3-8fb35eb7d28c2020-06-10WarningsExact identifier
spl id: a7bd439f-181e-9479-e053-2995a90aeb51
spl set id: 1ad2248f-e0fa-4618-a9b3-8fb35eb7d28c

Reported adverse events (FAERS/openFDA)#

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