FDA.reportPublic FDA data

Ms. Germ Safe ANTIBACTERIAL HAND SANITIZER SPRAY

Manufacturer
The Germ Safe Company Llc | GYP Comercio Atacadista de Cosmeticos Ltda
Effective date
2022-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:43

Label at a glance#

ProductMs.GermSafe Antibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available.

Dosage and administration

• 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

• 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

Uses

INDICATIONS & USAGE SECTION

• 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 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

+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

Distributed by: The Germ Safe Company, LLC 5 Rosalie Drive - Plainview, NY-11803

MADE IN BRAZIL

NDC: 74415-003-02

NDC: 74415-003-03

NDC: 74415-003-05

850018863094

850018863100

850018863117

70% ETHYL ALCOHOL

UNSCENTED

With Moisturizing
Aloe Vera and Vitamin E

HYPOALLERGENIC

36M

NOT TESTED ON ANIMALS

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

PackagingPackaging

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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74415-003-022024-01-30C16284748780-11030e365-04b7-111a-e063-dadaa90a10e2Ms. Germ Safe ANTIBACTERIAL HAND SANITIZER SPRAY
74415-003-032024-01-30C16284748780-11030e365-04b7-111a-e063-dadaa90a10e2Ms. Germ Safe ANTIBACTERIAL HAND SANITIZER SPRAY
74415-003-052024-01-30C16284748780-11030e365-04b7-111a-e063-dadaa90a10e2Ms. Germ Safe ANTIBACTERIAL HAND SANITIZER SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74415-003-02Ms.GermSafe Antibacterial Hand Sanitizer98 mL in 1 BOTTLE, SPRAYSPRAY983
74415-003-03Ms.GermSafe Antibacterial Hand Sanitizer148 mL in 1 BOTTLE, SPRAYSPRAY1483
74415-003-05Ms.GermSafe Antibacterial Hand Sanitizer250 mL in 1 BOTTLE, SPRAYSPRAY2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74415-003MS.GERMSAFE ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) SPRAY [THE GERM SAFE COMPANY LLC]3Legacy NDC, 3 package rows20220129_765d6ff0-281f-4ef3-8a74-3966e0c4ccb0.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
74415-00374415-003-02, 74415-003-03, 74415-003-05

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
71b1a4f3-09bd-42c1-b14a-31159a29ac4d765d6ff0-281f-4ef3-8a74-3966e0c4ccb02022-01-27WarningsExact identifier
spl id: 71b1a4f3-09bd-42c1-b14a-31159a29ac4d
spl set id: 765d6ff0-281f-4ef3-8a74-3966e0c4ccb0

Reported adverse events (FAERS/openFDA)#

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