FDA.reportPublic FDA data

SaniSmart 3

Manufacturer
Registered Chemicals Corporation
Effective date
2018-03-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:55

Label at a glance#

ProductSaniSmart 3
Active ingredientALCOHOL
Label structure11 sections

Storage and handling

Other information    •Do not store above 100° F (38° C)   •May discolor some fabrics

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethanol 70%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses    •For hand washing to decrease bacteria on the skin

            •Recommended for repeated use

WARNINGS SECTION

Warnings

For external use only.

Flammable, keep away from fire or flame.

When using this product avoid contact with eyes. In case of eye contact, flush eyes

thoroughly with water.

Stop use and ask a doctor if irritation or redness develop, 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.

DOSAGE & ADMINISTRATION SECTION

Directions    •Dispense an adeqaute amount in your palm to cover all surfaces of hands

completely.    •Rub hands together until dry   •Supervise children in the use of this product.

STORAGE AND HANDLING SECTION

Other information   •Do not store above 100° F (38° C)   •May discolor some fabrics

INACTIVE INGREDIENT SECTION

Inactive ingredients   Water (Aqua), Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf

Juice Panthenol

OTC - QUESTIONS SECTION

Questions or comments?   781-03-7800   •info@registeredchemicals.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72130-003-012020-01-31C16284748780-19d75b9cf-e5c4-f424-e053-dadaa90a57ceecfa5e4a-ed70-4f32-87ea-0e60c8dac3d0
72130-003-022020-01-31C16284748780-19d75b9cf-e5c4-f424-e053-dadaa90a57ceecfa5e4a-ed70-4f32-87ea-0e60c8dac3d0
72130-003-032020-01-31C16284748780-19d75b9cf-e5c4-f424-e053-dadaa90a57ceecfa5e4a-ed70-4f32-87ea-0e60c8dac3d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72130-003-01SaniSmart 31250 mL in 1 BOTTLE, SPRAYLIQUID12502
72130-003-02SaniSmart 31000 mL in 1 BOTTLE, SPRAYLIQUID10002
72130-003-03SaniSmart 33750 mL in 1 BOTTLELIQUID37502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72130-003SANISMART 3 (ETHANOL) LIQUID [REGISTERED CHEMICALS CORPORATION]2Legacy NDC, 3 package rows20180315_ecfa5e4a-ed70-4f32-87ea-0e60c8dac3d0.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
72130-00372130-003-01, 72130-003-02, 72130-003-03

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT

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
4ebfd119-ec0a-4e11-ac1d-5384e831f211ecfa5e4a-ed70-4f32-87ea-0e60c8dac3d02018-03-14WarningsExact identifier
spl id: 4ebfd119-ec0a-4e11-ac1d-5384e831f211
spl set id: ecfa5e4a-ed70-4f32-87ea-0e60c8dac3d0

Reported adverse events (FAERS/openFDA)#

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