FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Guide Energy Solutions LLC
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:02

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 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 15-30°C (59-83°F) • Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

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. Flammable.

Keep away from heat or flame.

Do not use

• in children less than 2 months 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 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.

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

STORAGE AND HANDLING SECTION

• Store between 15-30°C (59-83°F)

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

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, fragrance, water

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80% Topical Solution

Non-Sterile Solution

MADE IN THE USA

Guide Energy Solutions, LLC

9330 Hwy 99

Prague, OK 74864

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Santzr2Santzr2

Crst80Crst80

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

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
77042-180-012022-07-29C16284748780-1e4f33bdf-ac6d-d8a0-e053-dadaa90a6e4eHAND SANITIZER
77042-180-122022-07-29C16284748780-1e4f33bdf-ac6d-d8a0-e053-dadaa90a6e4eHAND SANITIZER
77042-180-322022-07-29C16284748780-1e4f33bdf-ac6d-d8a0-e053-dadaa90a6e4eHAND SANITIZER
77042-180-642022-07-29C16284748780-1e4f33bdf-ac6d-d8a0-e053-dadaa90a6e4eHAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77042-180-01Hand Sanitizer3.785 L in 1 JUGSOLUTION3.7853
77042-180-12Hand Sanitizer0.3548 L in 1 BOTTLESOLUTION0.35483
77042-180-32Hand Sanitizer0.946 L in 1 BOTTLESOLUTION0.9463
77042-180-64Hand Sanitizer1.9 L in 1 JUGSOLUTION1.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77042-180HAND SANITIZER (ALCOHOL) SOLUTION [GUIDE ENERGY SOLUTIONS LLC]3Legacy NDC, 4 package rows20211230_1a044335-4e2a-4f9c-b168-4cbf30f4b93b.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
77042-18077042-180-01, 77042-180-64, 77042-180-32, 77042-180-12

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
ALCOHOL3K9958V90MACTIB
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
aac62c67-351f-466a-b81c-4f9ba371f6781a044335-4e2a-4f9c-b168-4cbf30f4b93b2021-12-28WarningsExact identifier
spl id: aac62c67-351f-466a-b81c-4f9ba371f678
spl set id: 1a044335-4e2a-4f9c-b168-4cbf30f4b93b

Reported adverse events (FAERS/openFDA)#

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