FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Apotex Pharmachem Inc.
Effective date
2020-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:23

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientIsopropyl Alcohol
Label structure11 sections

Dosage and administration

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

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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol Antiseptic 75% Topical Solution, Hand Sanitizer Non-Sterile Solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Keep away from open flame and sources of heat.

Do not use

OTC - DO NOT USE SECTION

Do not use on children less than 2 months old.

Do not use on open skin wounds.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

Information required in 201.66(c)(5)(iv)

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

Information required in 201.66(c)(5)(v)

When using this product

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 doctor if

OTC - STOP USE SECTION

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

Other required warnings

WARNINGS SECTION

Information required in 201.66 (c)(5)(viii)

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Information required in 201.66(c)(5)(ix)

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, if swallowed, call a poison control center right away.

Directions

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.

Other information

SPL UNCLASSIFIED SECTION

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

Storage

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, water

Questions

OTC - QUESTIONS SECTION

Questions? 1-800-667-4708 or 1-416-401-7780 (follow prompts)

Report adverse reactions to the above numbers or drugsafety@apotex.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative sample of labeling: PRINCIPAL DISPLAY PANEL - DRUM LABEL ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION, HAND SANITIZER NON-STERILE SOLUTION: HANDLING UNIT #: NDC 49867-0072-0: BATCH NUMBER.: GROSS WT.: MFG. DATE: TARE WT.: RETEST DATE: NET WT.: CONTAINER NO.: STORAGE CONDITION: STORE BETWEEN 15-30C (59-86F): TRANSPORTATION CONDITION: AVOID FREEZING AND EXCESSIVE HEAT ABOUVE 40C (104F): LABEL SERIAL #: MANUFACTURED BY APOTEX PHARMACHEM INC.: MADE IN: CANADA

ipa0020200413ipa0020200413

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD1
1039900isopropyl alcohol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49867-0072-02022-01-28C16284748780-1d6a99b39-88cd-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49867-0072-0Isopropyl Alcohol208 kg in 1 DRUMSOLUTION2081

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49867-0072ISOPROPYL ALCOHOL SOLUTION [APOTEX PHARMACHEM INC.]1Legacy NDC, 1 package rows20200415_c8feea99-8b41-6657-da37-6aa321df09c5.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
49867-007249867-0072-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Isopropyl AlcoholND2M416302ACTIB
GlycerinPDC6A3C0OXIACT
Hydrogen PeroxideBBX060AN9VIACT
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
12454267-cfbc-a489-7929-67744ac2db16c8feea99-8b41-6657-da37-6aa321df09c52020-04-13WarningsExact identifier
spl id: 12454267-cfbc-a489-7929-67744ac2db16
spl set id: c8feea99-8b41-6657-da37-6aa321df09c5

Reported adverse events (FAERS/openFDA)#

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