FDA.reportPublic FDA data

4 Hour Power Hand Sanitizer

Manufacturer
Guide Energy Solutions LLC
Effective date
2021-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:32

Label at a glance#

Product4 Hour Power Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

Place enough product on your palm to thoroughly cover your hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed. Keep out of extreme temperatures.

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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 your palm to thoroughly cover your hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed. Keep out of extreme temperatures.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Lauramine Oxide, Dimethyltetradecylamine Oxide, DMDM Hydantoin (preservative), Fragrance*
*may contain this ingredient

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS

ALCOHOL FREE

FRESH ALOE SCENT

NON-FLAMMABLE

DYE FREE

NON-IRRITATING

MOISTURIZING FORMULA

NO STING

Long Lasting, Kills 99.9% of Germs for Up to 4 Hours

Outlasts Alcohol-Based Sanitizers by Persisting on Skin

Alcohol Free Formula Won't Dry Hands, Sting, or Cause Cracking

Leaves Skin Feeling Nourished and Moisturized

Paraben-Free, Sulfate-Free, Phthalate-Free

Foaming Formula

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77042-440-012022-07-29C16284748780-1e4f33bdf-9c3f-d8a0-e053-dadaa90a6e4e4 Hour Power Hand Sanitizer
77042-440-022022-07-29C16284748780-1e4f33bdf-9c3f-d8a0-e053-dadaa90a6e4e4 Hour Power Hand Sanitizer
77042-440-162022-07-29C16284748780-1e4f33bdf-9c3f-d8a0-e053-dadaa90a6e4e4 Hour Power Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77042-440-014 Hour Power Hand Sanitizer3785 mL in 1 JUGLIQUID37851
77042-440-024 Hour Power Hand Sanitizer59 mL in 1 BOTTLELIQUID591
77042-440-164 Hour Power Hand Sanitizer473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77042-4404 HOUR POWER HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [GUIDE ENERGY SOLUTIONS LLC]1Legacy NDC, 3 package rows20210410_1c2bc418-3149-4f0b-a3b8-fd1649263011.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77042-44077042-440-02, 77042-440-16, 77042-440-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
MYRISTAMINE OXIDEJ086PM3RRTIACT
DMDM HYDANTOINBYR0546TOWIACT

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
501a25ea-329f-49a5-ab22-c552a1fd047b1c2bc418-3149-4f0b-a3b8-fd16492630112021-04-06WarningsExact identifier
spl id: 501a25ea-329f-49a5-ab22-c552a1fd047b
spl set id: 1c2bc418-3149-4f0b-a3b8-fd1649263011

Reported adverse events (FAERS/openFDA)#

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