FDA.reportPublic FDA data

MELLOW INSTANT Hand Sanitizer 8 oz

Manufacturer
Ashtel Studios, Inc
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:33

Label at a glance#

ProductMELLOW INSTANT Hand Sanitizer 8 oz
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

♦ Wet hands thoroughly with product and rub until dry without wiping. ♦ For children under 6, use only under adult supervision. ♦ Not recommended for infants.

Storage and handling

♦ Do not store above 105°F  ♦ May discolor some fabrics,  ♦ Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Medicinal Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Non Medicinal

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Parfum, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, FD&C Yellow No. 5(Tartrazine), FD&C Blue No. 1

Features

INDICATIONS & USAGE SECTION

♦ To decrease bacteria on the skin that could cause disease.

♦ Recommended for repeated use.

♦ Use anywhere without water.

Directions

DOSAGE & ADMINISTRATION SECTION

♦ Wet hands thoroughly with product and rub until dry without wiping.

♦ For children under 6, use only under adult supervision.

♦ Not recommended for infants.

Warning

WARNINGS SECTION

♦ For external use only-hands. 

♦ Flammable. Keep away from heat and flame.

♦ Discontinue if skin becomes irritated and ask a doctor.

When using this product

♦ Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

♦ Do not inhale or ingest.

♦ Avoid contact with broken skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

♦ Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other information

STORAGE AND HANDLING SECTION

♦ Do not store above 105°F 

♦ May discolor some fabrics, 

♦ Harmful to wood finishes and plastics.

SPL UNCLASSIFIED SECTION

With Aloe and Vitamin E

Kills 99.99% of Germs

This product was not tested on animals.

Used under Lic. & Dist.By:

LANTERN BEAUTY AMERICA INC

Address: 1401 E, Cedar Street, Unit C, Ontario, CA 91761, USA

TEL: 909-799-9700

Web:LanternBeauty.com

Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-033-012024-01-30C16284748780-11030e365-1ffd-111a-e063-dadaa90a10e2MELLOW INSTANT Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-033-01MELLOW INSTANT Hand Sanitizer 8 oz236 mL in 1 BOTTLEGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-033MELLOW INSTANT HAND SANITIZER 8 OZ (ETHYL ALCOHOL) GEL [ASHTEL STUDIOS, INC]1Legacy NDC, 1 package rows20200417_63119a31-d751-4512-9b9f-9b2f692362d9.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-03370108-033-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
1c29df6c-baee-488c-8df1-0bd37d8cccb163119a31-d751-4512-9b9f-9b2f692362d92020-04-08WarningsExact identifier
spl id: 1c29df6c-baee-488c-8df1-0bd37d8cccb1
spl set id: 63119a31-d751-4512-9b9f-9b2f692362d9

Reported adverse events (FAERS/openFDA)#

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