FDA.reportPublic FDA data

Scigen Hand Sanitizer

Manufacturer
Scigen, Inc | Scigen Inc.
Effective date
2020-11-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:14

Label at a glance#

ProductScigen Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Storage and handling

Other Information:  •  Store below 86° F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Organic Ethanol 65%  v/v

OTC - PURPOSE SECTION

Purpose:

Antiseptic

INDICATIONS & USAGE SECTION

Uses: • Hand sanitizer to help reduce viruses and bacteria that potentially can cause disease • Recommended for repeated use 

WARNINGS SECTION

Warnings:

  • Flammable, keep away from fire or flame.
  • For external use only
  • Do not use in eyes. If contact occurs, flush thoroughly with water.
  • Stop use and ask a doctor if redness and irritation develop and 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 the Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: • Place enough product on hands to cover all surfaces. Rub hands together until dry • Do not use other than directed.

STORAGE AND HANDLING SECTION

Other Information: •  Store below 86° F

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified Water, Glycerin, Hydrogen Peroxide

SPL UNCLASSIFIED SECTION

Unscented

Scigen, Inc.

Paramount, CA.

info@scigenus.com

Made in U.S.A.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902515ethanol 65 % Topical SprayPSN3
902515ethanol 0.65 ML/ML Topical SpraySCD3
902515ethanol 65 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74510-001-022022-01-28C16284748780-1d6a99b39-cd56-a426-e053-dadaa90af4c2Scigen Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74510-001-01Scigen Hand Sanitizer110 mL in 1 BOTTLESPRAY1103
74510-001-02Scigen Hand Sanitizer12 in 1 BOXSPRAY123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74510-001SCIGEN HAND SANITIZER (ALCOHOL) SPRAY [SCIGEN, INC]3Legacy NDC, 2 package rows20201125_e3a7e601-e6ec-4bb7-bd47-a6cbbd3836dd.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
74510-00174510-001-01, 74510-001-02

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
b4d34edd-395d-3305-e053-2995a90a26c5e3a7e601-e6ec-4bb7-bd47-a6cbbd3836dd2020-11-23WarningsExact identifier
spl id: b4d34edd-395d-3305-e053-2995a90a26c5
spl set id: e3a7e601-e6ec-4bb7-bd47-a6cbbd3836dd

Reported adverse events (FAERS/openFDA)#

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