FDA.reportPublic FDA data

STRATON DISINFECTANT SPRAY

Manufacturer
Aerosoles Francomexicanos, S.A. de C.V.
Effective date
2022-01-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:44

Label at a glance#

ProductSTRATON
Active ingredientALCOHOL, N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)
Label structure11 sections

Indications and uses

HANDS; SHAKE WELL BEFORE USING. HOLD CAN VERTICALLY 6 - 8 INCHES FROM THE PALM OF YOUR HANDS AND SPRAY ENOUGH ON THE PALM. RUB THE PALM OF YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

Dosage and administration

SPRAY ENOUGH PRODUCT ON THE PALM TO RUB YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

ETHYL ALCOHOL

CATIONIC SURFACTANT

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

WATER, ANTIOXIDANT, FRAGRANCE, AND PROPELLANT: N-BUTANE, PROPANE

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

HANDS; SHAKE WELL BEFORE USING.

HOLD CAN VERTICALLY 6 - 8 INCHES FROM THE PALM OF YOUR HANDS AND SPRAY ENOUGH ON THE PALM.

RUB THE PALM OF YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

SPRAY ENOUGH PRODUCT ON THE PALM TO RUB YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

DO NOT APPLY NEAR FACE OR EYES

DO NOT ALLOW CHILDREN TO HANDLE THE PRODUCT

DO NOT USE ON CHILDREN UNDER 1 YEAR OLD.

DO NOT BURN OR PUNCTURE THE CONTAINER,

DO NOT USE NEAR THE EYES AND FLAME.

DO NOT EXPOSE TO HEAT, NOR INCINERATE IT.

DO NOT STORE IN TEMPERATURES ABOVE 124° F.

WARNINGS

WARNINGS SECTION

FLAMMABLE PRODUCT

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

DO NOT USE

OTC - DO NOT USE SECTION

DO NOT USE ON CHILDREN UNDER 1 YEAR OLD.

ASK A DOCTOR SECTION

OTC - ASK DOCTOR SECTION

EYE CONTACT

INGESTION

INHALATION

IN ANY CASE GET MEDICAL ATTENTION AND SHOW THIS LABEL

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STRATON DISINFECTANT SPRAY 420 mLSTRATON DISINFECTANT SPRAY 420 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80105-1000-22023-07-28C16284748780-1d6a99b39-e17c-a426-e053-dadaa90af4c2STRATON DISINFECTANT SPRAY
80105-1000-22022-01-30C16284748780-1d6a99b39-e17c-a426-e053-dadaa90af4c2STRATON DISINFECTANT SPRAY
80105-1000-22022-01-28C16284748780-1d6a99b39-e17c-a426-e053-dadaa90af4c2STRATON DISINFECTANT SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80105-1000-2STRATON420 mL in 1 CANAEROSOL4202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80105-1000STRATON (ALCOHOL) AEROSOL [AEROSOLES FRANCOMEXICANOS, S.A. DE C.V.]2Legacy NDC, 1 package rows20220129_ae4d5ae2-3cb6-7a8e-e053-2a95a90a98d0.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80105-100080105-1000-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
BUTANE6LV4FOR43RIACT
SODIUM NITRATE N-150GNX7H7XF7IACT
WATER059QF0KO0RIACT
PROPANET75W9911L6IACT
N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)G258TFN61XACTIB

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
d6adfc1a-d8f3-7559-e053-2995a90a7dcfae4d5ae2-3cb6-7a8e-e053-2a95a90a98d02022-01-28WarningsExact identifier
spl id: d6adfc1a-d8f3-7559-e053-2995a90a7dcf
spl set id: ae4d5ae2-3cb6-7a8e-e053-2a95a90a98d0

Reported adverse events (FAERS/openFDA)#

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