FDA.reportPublic FDA data

Hand Sanitizer Mist

Manufacturer
GTG WELLNESS CO., LTD. | Natural Korea Co., Ltd.
Effective date
2021-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:21

Label at a glance#

ProductHand Sanitizer Mist
Active ingredientAlcohol
Label structure14 sections

Indications and uses

■ to help reduce bacteria on skin.

Dosage and administration

■ Place enough sanitizer on hands to cover all surfaces. ■ Rub hands until dry. ■ Children should be supervised when using this product to avoid swallowing .

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% w/w

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Glycerin, Fragrance, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Sophora Angustifolia Root Extract

PURPOSE

OTC - PURPOSE SECTION

SANITIZER

WARNINGS

WARNINGS SECTION

• Flammable. Keep away from heat and flame.
• For external use only.
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Do not use
• on children less than 2 months old, or on open skin wounds.

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When using this product • avoid contact with eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor • if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center right away at (800) 222-1222.

Uses

INDICATIONS & USAGE SECTION

■ to help reduce bacteria on skin.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Place enough sanitizer on hands to cover all surfaces.
■ Rub hands until dry.
■ Children should be supervised when using this product to avoid swallowing .

Other information

OTHER SAFETY INFORMATION

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

Questions

OTC - QUESTIONS SECTION

• FCO Genesis I, Inc

• www.fcogen1.com

• 1-888-970-7617

71080-0022-1: Hand Sanitizer Mist (Bucks)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

71080-0022-2: Hand Sanitizer Mist (Bulls)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

71080-0022-3: Hand Sanitizer Mist (Celtics)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

71080-0022-4: Hand Sanitizer Mist (Clippers)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

71080-0022-5: Hand Sanitizer Mist (Golden State Warriors)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN1
1041849ethanol 0.7 ML/ML Topical SpraySCD1
1041849ethanol 70 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71080-0022-12023-07-28C16284748780-10191ceaa-6830-198a-e063-dbdaa90aec3e34bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c2
71080-0022-22023-07-28C16284748780-10191ceaa-6830-198a-e063-dbdaa90aec3e34bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c2
71080-0022-32023-07-28C16284748780-10191ceaa-6830-198a-e063-dbdaa90aec3e34bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c2
71080-0022-42023-07-28C16284748780-10191ceaa-6830-198a-e063-dbdaa90aec3e34bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c2
71080-0022-52023-07-28C16284748780-10191ceaa-6830-198a-e063-dbdaa90aec3e34bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71080-0022-1Hand Sanitizer Mist17 mL in 1 CARTONSPRAY171
71080-0022-2Hand Sanitizer Mist17 mL in 1 CARTONSPRAY171
71080-0022-3Hand Sanitizer Mist17 mL in 1 CARTONSPRAY171
71080-0022-4Hand Sanitizer Mist17 mL in 1 CARTONSPRAY171
71080-0022-5Hand Sanitizer Mist17 mL in 1 CARTONSPRAY171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71080-0022HAND SANITIZER MIST (ALCOHOL) SPRAY [GTG WELLNESS CO., LTD.]1Legacy NDC, 5 package rows20210515_34bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c2.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71080-002271080-0022-1, 71080-0022-2, 71080-0022-3, 71080-0022-4, 71080-0022-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GRAPEFRUITO82C39RR8CIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT

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
9dc30dd5-b6ba-4a1f-b985-2be17e16920234bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c22021-05-14WarningsExact identifier
spl id: 9dc30dd5-b6ba-4a1f-b985-2be17e169202
spl set id: 34bad76a-8e8b-4f75-9f2d-cc3c8a4ed8c2

Reported adverse events (FAERS/openFDA)#

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