FDA.reportPublic FDA data

Septihol Hand Sanitizer

Manufacturer
STERIS Corporation | Accra Pac, Inc. (Voyant Beauty)
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:37

Label at a glance#

ProductSeptihol Hand Sanitizer
Active ingredientAlcohol
Label structure9 sections

Indications and uses

To help decrease bacteria/germs on the skin that could cause disease. For use when soap and water are not available. Recommended for repeated use.

Dosage and administration

Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing until hands feel dry. Do not rinse or wipe off sanitizer.

Storage and handling

For best foam density store and use at a temperature of 55 - 85˚F (13 - 29˚C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v

Purposes

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To help decrease bacteria/germs on the skin that could cause disease. For use when soap and water are not available. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame. Do not puncture or incinerate. Do not store above 120ºF (49ºC).

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. If splashed in eyes, rinse immediately and thoroughly with water. Do not use on open wounds, Discontinue use if irritation/redness occurs.

OTC - STOP USE SECTION

Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing until hands feel dry. Do not rinse or wipe off sanitizer.

Other Information

STORAGE AND HANDLING SECTION

For best foam density store and use at a temperature of 55 - 85˚F (13 - 29˚C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Hydrofluorocarbon 152a, Isobutane, Emulsifying Wax, Cetyl lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STERIS®

SEPTIHOL™

HAND SANITIZER

Reorder Number:
625736

Contents:
9 oz (255g)

NDC# 0519-6257-36

Antiseptic

No-Rinse

62% Ethyl Alcohol by Volume

Manufactured for: STERIS Corporation
7501 Page Avenue ■ St. Louis, MO 63133 ■ USA
800-548-4873 ■ www.steris.com

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label
PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020364ethanol 62 % Topical SprayPSN2
1020364ethanol 0.62 ML/ML Topical SpraySCD2
1020364ethanol 62 % Topical SpraySY2
1020364ethyl alcohol 62 % Topical SpraySY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0519-6257-35Septihol Hand Sanitizer24 in 1 CASEAEROSOL, FOAM242
0519-6257-36Septihol Hand Sanitizer255 mL in 1 BOTTLEAEROSOL, FOAM2552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0519-6257SEPTIHOL HAND SANITIZER (ALCOHOL) AEROSOL, FOAM [STERIS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20231208_279c5c6f-bf45-499f-a5a2-ddb535382146.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0519-62570519-6257-36, 0519-6257-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
water059QF0KO0RIACT
1,1-Difluoroethane0B1U8K2ME0IACT
IsobutaneBXR49TP611IACT
Cetyl lactateA7EVH2RK4OIACT
Steareth-2V56DFE46J5IACT
Sodium BenzoateOJ245FE5EUIACT
SODIUM SESQUICARBONATEY1X815621JIACT

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
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
ndc (package): 0519-6257-36
ndc (package): 0519-6257-35
ndc (product): 0519-6257
ndc11 (package): 00519625735
ndc11 (package): 00519625736
spl id: 4d87d890-73c8-4d33-9469-e1451ed363d6
spl set id: 279c5c6f-bf45-499f-a5a2-ddb535382146

Reported adverse events (FAERS/openFDA)#

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