FDA.reportPublic FDA data

Elegant Maximum Fresh Hand Sanitizer

Manufacturer
EPOCH Cosmetics and Toiletries Industries LLC
Effective date
2020-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:16

Label at a glance#

ProductElegant Maximum Fresh Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry Children under 6 years of age be supervised when using ELEGANT.

Storage and handling

Store between 110F (43C) May discolor certain fabrics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash 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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years of age be supervised when using ELEGANT.

Other information

STORAGE AND HANDLING SECTION

  • Store between 110F (43C)
  • May discolor certain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alchohol, Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/ C10-30 Alkyl Acrylate Corssploymer, Aminomethyl Propanol, Fragrance (Parfum).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 5label 5label 4label 4label 3label 3label 2label 2labellabel000 ml NDC: 00000-000-00

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN1
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD1
581698isopropyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80309-001-012022-01-28C16284748780-1d6a99b39-9479-a426-e053-dadaa90af4c2adf5f319-d4fa-5843-e053-2a95a90ae4bf
80309-001-022022-01-28C16284748780-1d6a99b39-9479-a426-e053-dadaa90af4c2adf5f319-d4fa-5843-e053-2a95a90ae4bf
80309-001-032022-01-28C16284748780-1d6a99b39-9479-a426-e053-dadaa90af4c2adf5f319-d4fa-5843-e053-2a95a90ae4bf
80309-001-042022-01-28C16284748780-1d6a99b39-9479-a426-e053-dadaa90af4c2adf5f319-d4fa-5843-e053-2a95a90ae4bf
80309-001-062022-01-28C16284748780-1d6a99b39-9479-a426-e053-dadaa90af4c2adf5f319-d4fa-5843-e053-2a95a90ae4bf
80309-001-072022-01-28C16284748780-1d6a99b39-9479-a426-e053-dadaa90af4c2adf5f319-d4fa-5843-e053-2a95a90ae4bf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80309-001-01Elegant Maximum Fresh Hand Sanitizer50 mL in 1 BOTTLEGEL501
80309-001-02Elegant Maximum Fresh Hand Sanitizer100 mL in 1 BOTTLEGEL1001
80309-001-03Elegant Maximum Fresh Hand Sanitizer250 mL in 1 BOTTLE, PUMPGEL2501
80309-001-04Elegant Maximum Fresh Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
80309-001-06Elegant Maximum Fresh Hand Sanitizer1000 mL in 1 BOTTLE, PUMPGEL10001
80309-001-07Elegant Maximum Fresh Hand Sanitizer60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80309-001ELEGANT MAXIMUM FRESH HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [EPOCH COSMETICS AND TOILETRIES INDUSTRIES LLC]1Legacy NDC, 6 package rows20200829_adf5f319-d4fa-5843-e053-2a95a90ae4bf.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80309-00180309-001-01, 80309-001-02, 80309-001-03, 80309-001-04, 80309-001-06, 80309-001-07

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
adf5f46b-e960-32b5-e053-2995a90a2808adf5f319-d4fa-5843-e053-2a95a90ae4bf2020-08-28WarningsExact identifier
spl id: adf5f46b-e960-32b5-e053-2995a90a2808
spl set id: adf5f319-d4fa-5843-e053-2a95a90ae4bf

Reported adverse events (FAERS/openFDA)#

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