FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
CJ Spirits LLC
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:35:08

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80%v/v

Do Not Use

OTC - DO NOT USE SECTION

In children less than two years of age or on open skin wounds

Warnings

WARNINGS SECTION

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

Stop Use

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash occurs

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Instructions for use

INSTRUCTIONS FOR USE SECTION

Place enough product on your hand to cover all surfaces. Rub hands together until dry

Keep out of reach of children

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 immediately

Other information

STORAGE AND HANDLING SECTION

Store between 15-30C (59=86F)

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

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Place enough product on your hand to cover all surfaces. Rub hands together until dry.

Usage

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront Label

Active Ingredients purpose

Alcohol 80%v/v...........................................................................antiseptic

Uses

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

Warnings

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

Do not use

In children less than two years of age

on open skin wounds

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 irritation or rash occurs

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately

Place enough product on your hand 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

Store between 15-30C (59=86F)

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

Inactive ingredients, glycerin, hydrogen peroxide, purified water USP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN5
1039339ethanol 0.8 ML/ML Topical SolutionSCD5
1039339ethanol 80 % Topical SolutionSY5

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73912-100-012022-01-28C16284748780-1d6a99b39-e7a8-a426-e053-dadaa90af4c2a18a55f5-b3e8-56bc-e053-2a95a90ac2cd
73912-100-022022-01-28C16284748780-1d6a99b39-e7a8-a426-e053-dadaa90af4c2a18a55f5-b3e8-56bc-e053-2a95a90ac2cd
73912-100-032022-01-28C16284748780-1d6a99b39-e7a8-a426-e053-dadaa90af4c2a18a55f5-b3e8-56bc-e053-2a95a90ac2cd
73912-100-042022-01-28C16284748780-1d6a99b39-e7a8-a426-e053-dadaa90af4c2a18a55f5-b3e8-56bc-e053-2a95a90ac2cd
73912-100-052022-01-28C16284748780-1d6a99b39-e7a8-a426-e053-dadaa90af4c2a18a55f5-b3e8-56bc-e053-2a95a90ac2cd
73912-100-062022-01-28C16284748780-1d6a99b39-e7a8-a426-e053-dadaa90af4c2a18a55f5-b3e8-56bc-e053-2a95a90ac2cd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73912-100-01Hand Sanitizer118 mL in 1 BOTTLELIQUID1185
73912-100-02Hand Sanitizer750 mL in 1 BOTTLELIQUID7505
73912-100-03Hand Sanitizer118.3 mL in 1 BOTTLELIQUID118.35
73912-100-04Hand Sanitizer148 mL in 1 BOTTLELIQUID1485
73912-100-05Hand Sanitizer375 mL in 1 BOTTLELIQUID3755
73912-100-06Hand Sanitizer3785 mL in 1 BOTTLELIQUID37855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73912-100HAND SANITIZER (ETHYL ALCOHOL) LIQUID [CJ SPIRITS LLC]5Legacy NDC, 6 package rows20201215_a18a55f5-b3e8-56bc-e053-2a95a90ac2cd.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73912-10073912-100-01, 73912-100-02, 73912-100-03, 73912-100-04, 73912-100-05, 73912-100-06

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
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
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
accd83c2-7962-6420-e053-2a95a90a3b04a18a55f5-b3e8-56bc-e053-2a95a90ac2cd2020-08-13WarningsExact identifier
spl id: accd83c2-7962-6420-e053-2a95a90a3b04
spl set id: a18a55f5-b3e8-56bc-e053-2a95a90ac2cd

Reported adverse events (FAERS/openFDA)#

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