FDA.reportPublic FDA data

The Essence of Eva

Manufacturer
F & E Group LLP
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:46:07

Label at a glance#

ProductThe Essence of Eva
Active ingredientISOPROPYL ALCOHOL
Label structure14 sections

Label contents#

Full prescribing information#

Back Label NDC 79206-003-06

DRUG INTERACTIONS SECTION

drug interaction 79206-003-06drug interaction 79206-003-06

OTC - ACTIVE INGREDIENT SECTION

Active ingredient[s] Purpose

Isopropyl alcohol 70%v/v…….………….……………..................Antiseptic

OTC - PURPOSE SECTION

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS SECTION

Warnings

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

OTC - DO NOT USE SECTION

Do not use

• in children less than 2 months of age

• on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. 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 occurs. These may be signs of a serious condition.

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.

INDICATIONS & USAGE SECTION

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER SAFETY INFORMATION

Other information

• Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

NDC 79206-003

INACTIVE INGREDIENT SECTION

Inactive ingredients

Glycerin, Carbomer, Triisopropanolamine, Aloe Vera Juice, Iodopropynyl Butylcarbamate, Diazolidinyl Urea, hydrogen peroxide, fragrance,Argan Oil, purified water USP

Manufacture and Distribution Made in the USA by F & E Group LLP Kalamazoo, MI. 49004. Email: info@the-essenceofvea.com Text: (269)-267-2015 www.the-essenceofeva.com Batch No. 001 Mfg.: June /2020. Best Used within 1 year of Manufacture

STATEMENT OF IDENTITY SECTION

company infocompany info

DOSAGE & ADMINISTRATION SECTION

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Primary label front NDC 79206-003-06 236 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary label front NDC 79206-003-06 236 mLPrimary label front NDC 79206-003-06 236 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2384131isopropyl alcohol 70 % Topical LotionPSN4
2384131isopropyl alcohol 0.7 ML/ML Topical LotionSCD4
2384131isopropyl alcohol 70 % Topical LotionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79206-003-062022-07-29C16284748780-1e4f33bdf-a93d-d8a0-e053-dadaa90a6e4eaa597894-5471-d04d-e053-2a95a90a13ce

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79206-003-06The Essence of Eva236 mL in 1 BOTTLE, PUMPLOTION2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79206-003THE ESSENCE OF EVA (HAND SANITIZING LOTION) LOTION [F & E GROUP LLP]4Legacy NDC, 1 package rows20211231_aa597894-5471-d04d-e053-2a95a90a13ce.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
79206-00379206-003-06

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
ISOPROPYL ALCOHOLND2M416302ACTIB
ALOEV5VD430YW9IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ARGAN OIL4V59G5UW9XIACT

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
d45fb7d3-1aed-11f1-e053-2a95a90a896faa597894-5471-d04d-e053-2a95a90a13ce2021-12-30WarningsExact identifier
spl id: d45fb7d3-1aed-11f1-e053-2a95a90a896f
spl set id: aa597894-5471-d04d-e053-2a95a90a13ce

Reported adverse events (FAERS/openFDA)#

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