FDA.reportPublic FDA data

Extreme Sanitizer

Manufacturer
Earth Wind Fire L.L.C. / Extreme Sanitizer®
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:04

Label at a glance#

ProductExtreme Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

Extreme Sanitizer®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extreme Sanitizer®Extreme Sanitizer®

Extreme Sanitizer®

Kills 99.99% of Germs in 15 Seconds

Effective Hand Sanitizer

Advanced Formula

KILLS CORONAVIRUS IN 15 SECONDS

Hypoallergenic and ALCOHOL-FREE

Drug Facts

Active Ingredient:Alkylbenzyldimethylammonium
Chloride (Quaternary Ammonium) 0.13%…Antiseptic
Use: For hand sanitation. No water wash.
WARNING: Avoid eye contact, flush with
water. Keep out of reach of children.
STOP use if redness or irritation occurs.
Call poison control if swallowed.
Directions:Apply spray to full cover hands
and rub. Repetition increases the effect.
Inactive Ingredient: Water
Questions? info@extremesanitizer.com
Other information: Store at 56 – 86 oF

Earth Wind Fire L.L.C. The Woodlands, TX. 77382

www.extremesanitizer.com

2 FL OZ
(60 mL)

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:Alkylbenzyldimethylammonium
Chloride (Quaternary Ammonium) 0.13%…Antiseptic

Active IngredientActive Ingredient

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Active Ingredient:Alkylbenzyldimethylammonium
Chloride (Quaternary Ammonium) 0.13%…Antiseptic

Use: For hand sanitation. No water wash.

Directions:Apply spray to full cover hands
and rub. Repetition increases the effect.

Dosage and AdminDosage and Admin

Warning

WARNINGS SECTION

WARNING: Avoid eye contact, flush with
water. Keep out of reach of children.

WarningWarning

Other Information

OTC - WHEN USING SECTION

Other information: Store at 56 – 86 oF

Other InfoOther Info

Questions

OTC - QUESTIONS SECTION

Questions? info@extremesanitizer.com QuestionsQuestions

Use and Purpose

OTC - PURPOSE SECTION

Antiseptic
Use: For hand sanitation. No water wash.

UseUse

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNING: Avoid eye contact, flush with
water. Keep out of reach of children.

WaringWaring

Do Not Use Stop Use

OTC - DO NOT USE SECTION

WARNING: Avoid eye contact, flush with
water. Keep out of reach of children.
STOP use if redness or irritation occurs.
Call poison control if swallowed.

Do not UseDo not Use

Stop Use

OTC - ASK DOCTOR SECTION

WARNING: Avoid eye contact, flush with
water. Keep out of reach of children.
STOP use if redness or irritation occurs.
Call poison control if swallowed.

Stop UseStop Use

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNING: Avoid eye contact, flush with
water. Keep out of reach of children.

No childrenNo children

Stop Use

OTC - STOP USE SECTION

STOP use if redness or irritation occurs.
Call poison control if swallowed.

Stop UseStop Use

Indication and Usage

INDICATIONS & USAGE SECTION

Use: For hand sanitation. No water wash.

Directions:Apply spray to full cover hands
and rub. Repetition increases the effect.

Indication and usageIndication and usage

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Water

Inactive IngredientInactive Ingredient

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN2
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD2
1039012benzalkonium chloride 0.13 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77868-0001-12022-01-28C16284748780-1d6a99b39-9b8a-a426-e053-dadaa90af4c2Extreme Hand Sanitizer®
77868-0001-22022-01-28C16284748780-1d6a99b39-9b8a-a426-e053-dadaa90af4c2Extreme Hand Sanitizer®
77868-0001-32022-01-28C16284748780-1d6a99b39-9b8a-a426-e053-dadaa90af4c2Extreme Hand Sanitizer®
77868-0001-42022-01-28C16284748780-1d6a99b39-9b8a-a426-e053-dadaa90af4c2Extreme Hand Sanitizer®
77868-0001-52022-01-28C16284748780-1d6a99b39-9b8a-a426-e053-dadaa90af4c2Extreme Hand Sanitizer®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77868-0001-1Extreme Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID602
77868-0001-2Extreme Sanitizer250 mL in 1 BOTTLE, SPRAYLIQUID2502
77868-0001-3Extreme Sanitizer500 mL in 1 BOTTLE, SPRAYLIQUID5002
77868-0001-4Extreme Sanitizer1000 mL in 1 BOTTLE, SPRAYLIQUID10002
77868-0001-5Extreme Sanitizer3875.41 mL in 1 BOTTLE, PLASTICLIQUID3875.412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77868-0001EXTREME SANITIZER (HAND SANITIZER) LIQUID [EARTH WIND FIRE L.L.C. / EXTREME SANITIZER®]2Legacy NDC, 5 package rows20201230_a5926392-d9ff-69a2-e053-2995a90a9c8f.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
77868-000177868-0001-1, 77868-0001-2, 77868-0001-3, 77868-0001-4, 77868-0001-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
b791be4e-4ee4-778d-e053-2a95a90a31fea5926392-d9ff-69a2-e053-2995a90a9c8f2020-12-28WarningsExact identifier
spl id: b791be4e-4ee4-778d-e053-2a95a90a31fe
spl set id: a5926392-d9ff-69a2-e053-2995a90a9c8f

Reported adverse events (FAERS/openFDA)#

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