FDA.reportPublic FDA data

Mellow Land Hand Sanitizer gel

Manufacturer
815Healthy & Beautiful Co.,Ltd. | JUHWANBIO.CELL CO.,LTD.
Effective date
2020-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:45

Label at a glance#

ProductMellow Land Hand Sanitizer gel
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping

Storage and handling

Store below 110°F (43°C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 68% w/w

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • To decrease bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Dipropylene Glycol, Tocopheryl Acetate, Carbomer, Triethanolamine, Hyaluronic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037039ethanol 68 % Topical GelPSN1
1037039ethanol 0.68 ML/ML Topical GelSCD1
1037039ethanol 68 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79210-002-012022-01-28C16284748780-1d6a99b39-f6e3-a426-e053-dadaa90af4c279210-002_Mellow Land Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79210-002-01Mellow Land Hand Sanitizer gel500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79210-002MELLOW LAND HAND SANITIZER GEL (ALCOHOL) GEL [815HEALTHY & BEAUTIFUL CO.,LTD.]1Legacy NDC, 1 package rows20200624_927b53a8-a0e6-4268-844c-cbf5bebdcd2a.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
79210-00279210-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIPROPYLENE GLYCOLE107L85C40IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
HYALURONIC ACIDS270N0TRQYIACT
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
a8c7f261-39c3-44d9-e053-2995a90ae2a6927b53a8-a0e6-4268-844c-cbf5bebdcd2a2020-06-23WarningsExact identifier
spl id: a8c7f261-39c3-44d9-e053-2995a90ae2a6
spl set id: 927b53a8-a0e6-4268-844c-cbf5bebdcd2a

Reported adverse events (FAERS/openFDA)#

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