FDA.reportPublic FDA data

DermEssentials Advanced Hand Sanitizer

Manufacturer
SmartScience Laboratories, Inc.
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:42

Label at a glance#

ProductDermEssentials Advanced Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

wet hands thoroughly with product and allow to 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 plastic

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only: hands

  • Flammable, keep away from fire or flame.

When Using this product

OTC - WHEN USING SECTION

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hrs

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
  • for children under 6, use only under adult supervision
  • not recommended for infants

Other Information

STORAGE AND HANDLING SECTION

  • do not store above 105 F
  • may discolor some fabrics
  • harmful to wood finishes and plastic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Aloe Vera, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Vitamin E, EDTA

Questions? Comments?

OTC - QUESTIONS SECTION

813-925-8454

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermEssentials™

Advanced
GEL
Hand Sanitizer

KILLS 99.99% OF MOST ILLNESS
CAUSING GERMS

  • 70% Ethyl Alcohol
  • With Vitamin E and Aloe
  • Leaves hands soft
  • Fast and Effective

8 FL OZ (236 mL)

Principal Display Panel - 236 mL Bottle Label
Principal Display Panel - 236 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64479-501-012024-01-30C16284748780-11030e365-43c1-111a-e063-dadaa90a10e2DermEssentials™ Advanced Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64479-501-01DermEssentials Advanced Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64479-501DERMESSENTIALS ADVANCED HAND SANITIZER (ALCOHOL) GEL [SMARTSCIENCE LABORATORIES, INC.]1Legacy NDC, 1 package rows20200506_77556529-24f5-4fea-9d43-c3b1f841e6a1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64479-50164479-501-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
LIMONENE, (+)-GFD7C86Q1WIACT

Source Document#

Source XML · Source PDF

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
3d7312f9-1486-4337-868d-26a4348a22c077556529-24f5-4fea-9d43-c3b1f841e6a12020-05-05WarningsExact identifier
spl id: 3d7312f9-1486-4337-868d-26a4348a22c0
spl set id: 77556529-24f5-4fea-9d43-c3b1f841e6a1

Reported adverse events (FAERS/openFDA)#

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