FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 70%

Manufacturer
Artesanales P.R. LLC
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:06:30

Label at a glance#

ProductISOPROPYL RUBBING ALCOHOL 70%
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Storage and handling

store between 15-30C (59-86F) avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using grade ingredients:

Isopropyl Alcohol (USP or Food Chemical Codex) (99% (v/v) in an aqueous solution

water

the firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 99% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that can potentially cause a disease. For use when soap and water are not available

OTC - DO NOT USE SECTION

in children less than 2 onths of age

on open skin wounds

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irrittion or rash occurs. These may be signs of a serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING SECTION

store between 15-30C (59-86F)

avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isopropyl labelIsopropyl label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN1
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD1
808520isopropyl alcohol 70 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78824-625-012025-07-29C16284748780-13b156c62-30c2-fb37-e063-e6dba90a4e070e0f039e-054d-7963-e063-6294a90a1de1
78824-625-022025-07-29C16284748780-13b156c62-30c2-fb37-e063-e6dba90a4e070e0f039e-054d-7963-e063-6294a90a1de1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78824-625-01ISOPROPYL RUBBING ALCOHOL 70%473 mL in 1 BOTTLELIQUID4731
78824-625-02ISOPROPYL RUBBING ALCOHOL 70%3785 mL in 1 BOTTLELIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78824-625ISOPROPYL RUBBING ALCOHOL 70% (ALCOHOL) LIQUID [ARTESANALES P.R. LLC]12 package rows20240104_0e0f039e-054d-7963-e063-6294a90a1de1.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78824-62578824-625-01, 78824-625-02

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
0e0f039e-054e-7963-e063-6294a90a1de10e0f039e-054d-7963-e063-6294a90a1de12024-01-03WarningsExact identifier
spl id: 0e0f039e-054e-7963-e063-6294a90a1de1
spl set id: 0e0f039e-054d-7963-e063-6294a90a1de1

Reported adverse events (FAERS/openFDA)#

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