FDA.reportPublic FDA data

Sani Soft

Manufacturer
American Industrial Supply, Inc. | ABC Compounding Co., Inc. | ABC Compounding Company of Texas, Inc.
Effective date
2010-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:52

Label at a glance#

ProductSani Soft
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

for hand-washing to decrease bacteria on the skin, only when water is not available

Label contents#

Full prescribing information#

Drug Facts Box OTC-Active Ingredients Section

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

OTC - PURPOSE SECTION

Antiseptic

Drug Facts Box OTC-Indications and Usage Section

INDICATIONS & USAGE SECTION

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

WARNINGS SECTION

Flammable, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

OTC - WHEN USING SECTION

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

OTC - STOP USE SECTION

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Drug Facts Box OTC-Dosage & Administration Section

DOSAGE & ADMINISTRATION SECTION

press valve once to deliver one squirt (about a quarter size) of foaming product onto the palm of your hand

rub hands together and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredients Section

INACTIVE INGREDIENT SECTION

water, DEA-C8-18 perfluoroalkylethyl phosphate, cetearyl alcohol, polysorbate 65, dimethicone PEG-8 meadowfoamate, meadowfoamamidopropyl betaine, butane, propane, fragrance

Sani Soft 4773 199g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

477307P5115.jpg  Sani Soft 199gimage of aerosol labelimage of aerosol label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616763ethanol 62 % Topical FoamPSN1
616763ethanol 0.62 ML/ML Topical FoamSCD1
616763ethanol 62 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50519-773-252019-10-21C16284748780-1956f9ecf-cae9-621f-e053-dbdaa90a74adSani Soft 4773 Drug Facts and Label
50519-773-262019-10-21C16284748780-1956f9ecf-cae9-621f-e053-dbdaa90a74adSani Soft 4773 Drug Facts and Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50519-773-25Sani Soft199 g in 1 CANAEROSOL, FOAM1991
50519-773-26Sani Soft454 g in 1 CANAEROSOL, FOAM4541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50519-773SANI SOFT (ALCOHOL) AEROSOL, FOAM [AMERICAN INDUSTRIAL SUPPLY, INC.]1Legacy NDC, 2 package rows20100311_c848fcb0-342c-4203-bdc2-e3fe6e374835.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
BUTANEINACTIVE INGREDIENT6LV4FOR43R1
PROPANEINACTIVE INGREDIENTT75W9911L61
WATERINACTIVE INGREDIENT059QF0KO0R1

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
50519-77350519-773-25, 50519-773-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
PROPANET75W9911L6IACT
BUTANE6LV4FOR43RIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / RECTAL12 mgExact identifier — unii candidate
3 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / RECTAL9 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
73ed2d6c-2168-47c6-81f4-6b5dc0b75335c848fcb0-342c-4203-bdc2-e3fe6e3748352010-03-03WarningsExact identifier
spl id: 73ed2d6c-2168-47c6-81f4-6b5dc0b75335
spl set id: c848fcb0-342c-4203-bdc2-e3fe6e374835

Reported adverse events (FAERS/openFDA)#

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