FDA.reportPublic FDA data

Clean31

Manufacturer
S3 Surface Solutions, LLC | Polyventive LLC | Guide Energy Solutions | Emerald 66 Enterprises LLC
Effective date
2021-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:39

Label at a glance#

ProductClean31
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

For hand and skin sanitizing to decrease microbes on skin

Dosage and administration

Dispense an adequate amount in palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Clean 31Clean 31

Purpose

OTC - PURPOSE SECTION

Skin Anticeptic

Uses

INDICATIONS & USAGE SECTION

For hand and skin sanitizing to decrease microbes on skin

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

OTC - ASK DOCTOR SECTION

If irritation or redness develops, or if condition persists for more than 72 hours

Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Dispense an adequate amount in palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Colloidal Silicon Dioxide

Questions?

OTC - QUESTIONS SECTION

email info@S3Surfaces.com

Alcohol-Free Formulation

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

S3 Surface Protect, Quality branded Clean31 Protection, Hand Sanitizer, Sanitizes, Protects up to 4 hours, Alcohol-Free, Fragrance-free, Up to 4 hours of Protection, Kills over 99.9% of Germs

Hand Sanitizer Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label picture

Clean31Clean31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81300-100-012022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-022022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-032022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-042022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-052022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-062022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-072022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e
81300-100-082022-07-29C16284748780-1e4f33bdf-b1ee-d8a0-e053-dadaa90a6e4eb5f84376-1f92-ebe6-e053-2a95a90a821e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81300-100-01Clean3150 mL in 1 BOTTLE, PUMPLIQUID502
81300-100-02Clean31500 mL in 1 BOTTLELIQUID5002
81300-100-03Clean311000 mL in 1 BOTTLELIQUID10002
81300-100-04Clean311000 mL in 1 BOTTLE, SPRAYLIQUID10002
81300-100-05Clean313785.41 mL in 1 JUGLIQUID3785.412
81300-100-06Clean3118927.1 mL in 1 PAILLIQUID18927.12
81300-100-07Clean31208198 mL in 1 DRUMLIQUID2081982
81300-100-08Clean311249000 mL in 1 CONTAINERLIQUID12490002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81300-100CLEAN31 (BENZALKONIUM CHLORIDE) LIQUID [S3 SURFACE SOLUTIONS, LLC]2Legacy NDC, 8 package rows20210108_b5f84376-1f92-ebe6-e053-2a95a90a821e.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
81300-10081300-100-01, 81300-100-02, 81300-100-03, 81300-100-04, 81300-100-05, 81300-100-06, 81300-100-07, 81300-100-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT

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
b8520048-48da-192b-e053-2995a90ab5c7b5f84376-1f92-ebe6-e053-2a95a90a821e2021-01-07WarningsExact identifier
spl id: b8520048-48da-192b-e053-2995a90ab5c7
spl set id: b5f84376-1f92-ebe6-e053-2a95a90a821e

Reported adverse events (FAERS/openFDA)#

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