FDA.reportPublic FDA data

Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY UNSCENTED

Manufacturer
Germ Safe Company, Inc., The
Effective date
2022-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:42

Label at a glance#

ProductMs. Germsafe ANTIBACTERIAL HAND SANITIZER - UNSCENTED
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other information • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses • hand sanitizer to decrease bacteria on the skin

         • recommended for repeated use

         • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

For external use only

Do not use • in children less than 2 months of age • on open skin wounds.

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING SECTION

Other information• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT SECTION

Inactive ingredients water, glycerin, aloe vera ( Aloe Barbadensis) leaf extract, hydrogen peroxide, vitamin E, denatonium benzoate.

OTC - QUESTIONS SECTION

Questions? +1-909-442-0096

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

70% ETHYL ALCOHOL

With Moisturizing

Aloe Vera and Vitamin E

HYPOALLERGENIC

Distributed by: The Germ Safe Company, Inc.,

701 Brickell Key Boulevard, #1903

Miami, FL - 33131

MADE IN BRAZIL

NOT TESTED ON ANIMALS

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN3
1041849ethanol 0.7 ML/ML Topical SpraySCD3
1041849ethanol 70 % Topical SpraySY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79774-003-022024-01-30C16284748780-11030e365-0e2d-111a-e063-dadaa90a10e2Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY UNSCENTED
79774-003-032024-01-30C16284748780-11030e365-0e2d-111a-e063-dadaa90a10e2Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY UNSCENTED
79774-003-052024-01-30C16284748780-11030e365-0e2d-111a-e063-dadaa90a10e2Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY UNSCENTED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79774-003-02Ms. Germsafe ANTIBACTERIAL HAND SANITIZER - UNSCENTED98 mL in 1 BOTTLESPRAY983
79774-003-03Ms. Germsafe ANTIBACTERIAL HAND SANITIZER - UNSCENTED148 mL in 1 BOTTLESPRAY1483
79774-003-05Ms. Germsafe ANTIBACTERIAL HAND SANITIZER - UNSCENTED250 mL in 1 BOTTLESPRAY2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79774-003MS. GERMSAFE ANTIBACTERIAL HAND SANITIZER - UNSCENTED (ETHYL ALCOHOL) SPRAY [GERM SAFE COMPANY, INC., THE]3Legacy NDC, 3 package rows20220129_08a73e8a-72be-405c-8eb2-299aabb1bd89.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
79774-00379774-003-02, 79774-003-03, 79774-003-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
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
d350a2d8-e5a2-4bfd-b1f8-8634bd5984a708a73e8a-72be-405c-8eb2-299aabb1bd892022-01-27WarningsExact identifier
spl id: d350a2d8-e5a2-4bfd-b1f8-8634bd5984a7
spl set id: 08a73e8a-72be-405c-8eb2-299aabb1bd89

Reported adverse events (FAERS/openFDA)#

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