Safe Source 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#

ProductSafe Source Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

Spray 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.

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

Stop use if:

OTC - STOP USE SECTION

Skin irritation or redness develop or increase contact a doctor.

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

  • Spray 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, Fragance, Propanediol, Polysorbate 20, Glycerin

SPL UNCLASSIFIED SECTION

Store 59°-86°F. Avoid freezing heat above 104°F

CKI Solutions is USA distributor for O'ustane

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79128-001-012022-01-28C16284748780-1d6a99b39-75e3-a426-e053-dadaa90af4c2Safe Source Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79128-001-01Safe Source Hand Sanitizer50 mL in 1 BOTTLEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79128-001SAFE SOURCE HAND SANITIZER (ALCOHOL) GEL [CADENCE KEEN INNOVATIONS, INC.]1Legacy NDC, 1 package rows20200630_a939b6ec-e70a-c80f-e053-2a95a90ad0f5.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
79128-00179128-001-01

Ingredients#

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

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

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
a939b6ec-e70b-c80f-e053-2a95a90ad0f5a939b6ec-e70a-c80f-e053-2a95a90ad0f52020-06-29WarningsExact identifier
spl id: a939b6ec-e70b-c80f-e053-2a95a90ad0f5
spl set id: a939b6ec-e70a-c80f-e053-2a95a90ad0f5

Reported adverse events (FAERS/openFDA)#

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