FDA.reportPublic FDA data

Oustane Hand Sanitizer

Manufacturer
Cadence Keen Innovations, Inc.
Effective date
2020-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:30

Label at a glance#

ProductOustane Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand washing to reduce bacteria on skin, suitable when water is unavailable

Dosage and administration

Pour suitable enough product in your palm and rub together until dry. Children under 8 years of age should be used under supervision.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand washing to reduce bacteria on skin, suitable when water is unavailable

Warnings

WARNINGS SECTION

External Use only
Flammable, keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes, rinse thoroughly with water if contact occurs

Stop using and ask a doctor if

OTC - STOP USE SECTION

Skin irritation or redness develop or increase

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pour suitable enough product in your palm and rub together until dry.
  • Children under 8 years of age should be used under supervision.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Parfum(fragance), Propanediol, Polysorbate 20, Glycerin

Other Information

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Package Labeling: 50ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:3.785L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79128-000-012022-01-28C16284748780-1d6a99b39-f68e-a426-e053-dadaa90af4c2O'ustane Hand Sanitizer
79128-000-162022-01-28C16284748780-1d6a99b39-f68e-a426-e053-dadaa90af4c2O'ustane Hand Sanitizer
79128-000-372022-01-28C16284748780-1d6a99b39-f68e-a426-e053-dadaa90af4c2O'ustane Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79128-000-01Oustane Hand Sanitizer50 mL in 1 BOTTLEGEL501
79128-000-16Oustane Hand Sanitizer500 mL in 1 BOTTLEGEL5001
79128-000-37Oustane Hand Sanitizer3785 mL in 1 DRUMGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79128-000OUSTANE HAND SANITIZER (ALCOHOL) GEL [CADENCE KEEN INNOVATIONS, INC.]1Legacy NDC, 3 package rows20200630_a938eb43-b82c-0f5c-e053-2995a90a3308.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79128-00079128-000-01, 79128-000-16, 79128-000-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

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
a9392820-8a34-09c5-e053-2995a90a9954a938eb43-b82c-0f5c-e053-2995a90a33082020-06-29WarningsExact identifier
spl id: a9392820-8a34-09c5-e053-2995a90a9954
spl set id: a938eb43-b82c-0f5c-e053-2995a90a3308

Reported adverse events (FAERS/openFDA)#

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