FDA.reportPublic FDA data

Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY TROPICAL COCONUT

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 23:47:46

Label at a glance#

ProductMs. Germsafe ANTIBACTERIAL HAND SANITIZER -TROPICAL COCONUT
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, fragrance, limonene, aloe vera (Aloe barbadensis) leaf extract, bronopol, dichlorobenzyl alcohol, linalool, hexyl cinnamal, lactic acid, phenoxyethanol, butylphenyl methylpropional, citric acid, caprylyl glycol, citronellol, vitamin E, sodium benzoate, benzyl alcohol, geraniol, citral, amyl cinnamal, benzyl benzoate, 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

Kills 99.9% of bacteria*

With Moisturizing

Aloe Vera and Vitamin E

70% ETHYL ALCOHOL

NOT TESTED ON ANIMALS

Distributed by: The Germ Safe Company, Inc.,

701 Brickell Key Boulevard, #1903  Miami, FL - 33131 

MADE IN BRAZIL

*Tested under lab conditions.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79774-002-022024-01-30C16284748780-11030e365-4f08-111a-e063-dadaa90a10e2Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY TROPICAL COCONUT
79774-002-032024-01-30C16284748780-11030e365-4f08-111a-e063-dadaa90a10e2Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY TROPICAL COCONUT
79774-002-052024-01-30C16284748780-11030e365-4f08-111a-e063-dadaa90a10e2Ms. Germsafe™ ANTIBACTERIAL HAND SANITIZER SPRAY TROPICAL COCONUT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79774-002-02Ms. Germsafe ANTIBACTERIAL HAND SANITIZER -TROPICAL COCONUT98 mL in 1 BOTTLESPRAY983
79774-002-03Ms. Germsafe ANTIBACTERIAL HAND SANITIZER -TROPICAL COCONUT148 mL in 1 BOTTLESPRAY1483
79774-002-05Ms. Germsafe ANTIBACTERIAL HAND SANITIZER -TROPICAL COCONUT250 mL in 1 BOTTLESPRAY2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79774-002MS. GERMSAFE ANTIBACTERIAL HAND SANITIZER -TROPICAL COCONUT (ETHYL ALCOHOL) SPRAY [GERM SAFE COMPANY, INC., THE]3Legacy NDC, 3 package rows20220129_c0a9b0f9-e475-4e36-b846-23353bb21f19.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79774-00279774-002-02, 79774-002-03, 79774-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALOE VERA LEAFZY81Z83H0XIACT
BRONOPOL6PU1E16C9WIACT
DICHLOROBENZYL ALCOHOL1NKX3648J9IACT
LINALOOL, (+/-)-D81QY6I88EIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZYL ALCOHOLLKG8494WBHIACT
GERANIOLL837108USYIACT
CITRALT7EU0O9VPPIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
BENZYL BENZOATEN863NB338GIACT
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
1bed3abe-ccfd-419c-9cbc-75a1e8d3cc33c0a9b0f9-e475-4e36-b846-23353bb21f192022-01-27WarningsExact identifier
spl id: 1bed3abe-ccfd-419c-9cbc-75a1e8d3cc33
spl set id: c0a9b0f9-e475-4e36-b846-23353bb21f19

Reported adverse events (FAERS/openFDA)#

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