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

Manufacturer
Sarkli-Repechage, Ltd.
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:08:13

Label at a glance#

ProductIsopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-Sterile Solution
Active ingredientISOPROPYL ALCOHOL
Label structure14 sections

Storage and handling

Other information • Store between 15–30C (59–86F) • Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts
Active ingredient[s] Purpose
Isopropyl alcohol 75% v/v..........................................................................Antiseptic

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use
• in children less than 2 months of age
• on open skin wounds

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.

OTC - STOP USE SECTION

Stop and ask a doctor if irritation 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

Directions
• 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.

INSTRUCTIONS FOR USE SECTION

Directions
• 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

Other information
• Store between 15–30C (59–86F)
• Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purfied water USP

OTC - QUESTIONS SECTION

Questions or comments?
Call Toll-Free 1-800-248-SKIN (1-800-248-7546) Monday-Friday 9am-5:30pm ET

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 mL NDC 64521-1234-4 118 mL Label118 mL Label

59 mL NDC 64521-1234-2

59 mL Label59 mL Label

473 mL NDC 64521-1234-1

473 mL label473 mL label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN2
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD2
1039900isopropyl alcohol 75 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64521-1234-1Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-Sterile Solution473 mL in 1 BOTTLESOLUTION4732
64521-1234-2Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-Sterile Solution59 mL in 1 BOTTLE, SPRAYSOLUTION592
64521-1234-4Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-Sterile Solution118 mL in 1 BOTTLE, SPRAYSOLUTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64521-1234ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION SOLUTION [SARKLI-REPECHAGE, LTD.]2Legacy NDC, 3 package rows20200428_a19d53d2-d38c-3fe2-e053-2995a90a226b.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64521-123464521-1234-4, 64521-1234-2, 64521-1234-1

Ingredients#

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

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

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
a4484fab-8f1a-1781-e053-2995a90a9bb9a19d53d2-d38c-3fe2-e053-2995a90a226b2020-04-27WarningsExact identifier
spl id: a4484fab-8f1a-1781-e053-2995a90a9bb9
spl set id: a19d53d2-d38c-3fe2-e053-2995a90a226b

Reported adverse events (FAERS/openFDA)#

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