FDA.reportPublic FDA data

rareEssence Gel Well Hand Sanitizer

Manufacturer
rareESSENCE, LLC | Diversified Manufacturing Corporation
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:44

Label at a glance#

ProductrareEssence Gel Well Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Hand and Antiseptic

INDICATIONS & USAGE SECTION

Hand and skin antiseptic to help decrease pathogens (germs) on the skin

WARNINGS SECTION

For external use only

Flammable: Keep away from heat and flame

OTC - WHEN USING SECTION

* Avoid contact with eyes. If contact occurs flush eyes thoroughly with clean and cold water

* Do not ingest or inhale

OTC - ASK DOCTOR SECTION

* If irritation or redness develops, and/or you have open wounds or serious burns.

OTC - STOP USE SECTION

* If irritation or redness develops

* Have open wounds or serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

* If swallowed get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

* Wet hands thourhgly with product and allow to dry without wiping

* Supervise children under 6 years of age

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Orange Oil, Lemon Oil, Lavender Oil, Lavandin Oil, Vitamin E, Carbomer, Dimethicone, Aminomethyl Propanol

OTC - QUESTIONS SECTION

Questions? 800-998-1762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

rareESSENCE Gel Well(TM) Hand Sanitizer

Alcohol Antiseptic 70%

with Pure Essential Oils

Lavender orange

Feel good, Do good.

For every bottle you purchase, we will donate a portion of the proceeds to U.S. food shelves

With 100% pure Essential Oils

No Synthetic Fragrances

No Phthalates

No Parabens

Reduces Germs that can potentially cause disease

Washing hands wiht souap and warm water remains the best way to remvoe germs.

For use when soap and water are not available

Made in USA

rareEssence, LLC

Minneapolis, MN 55344

www,rareESSENCEaromatherapy.com

xx oz(zzzmL) NDC 78035-002-xx

Gel Well Hand sanitizer 12x8ozGel Well Hand sanitizer 12x8oz

Gel Well Hand sanitizer 8ozGel Well Hand sanitizer 8oz

Gel Well Hand sanitizer 48x4ozGel Well Hand sanitizer 48x4oz

Gel Well Hand sanitizer 12x4ozGel Well Hand sanitizer 12x4oz

Gel Well Hand sanitizer 4ozGel Well Hand sanitizer 4oz

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
78035-002-092023-01-30C16284748780-1f386c649-cc82-0266-e053-dadaa90a7c1aDrug Facts
78035-002-112023-01-30C16284748780-1f386c649-cc82-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78035-002-07rareEssence Gel Well Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
78035-002-08rareEssence Gel Well Hand Sanitizer12 in 1 CASEGEL121
78035-002-09rareEssence Gel Well Hand Sanitizer48 in 1 CARTONGEL481
78035-002-10rareEssence Gel Well Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2361
78035-002-11rareEssence Gel Well Hand Sanitizer12 in 1 CARTONGEL121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78035-002RAREESSENCE GEL WELL HAND SANITIZER (ETHYL ALCOHOL) GEL [RAREESSENCE, LLC]1Legacy NDC, 5 package rows20200609_a79dd0bd-9f95-70cf-e053-2a95a90a8366.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78035-00278035-002-07, 78035-002-08, 78035-002-09, 78035-002-10, 78035-002-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROLH4N855PNZ1IACT
CARBOMER 9404Q93RCW27EIACT
ORANGE OILAKN3KSD11BIACT
LAVENDER OILZBP1YXW0H8IACT
LAVANDIN OIL9RES347CKGIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
LEMON OILI9GRO824LLIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE 3502Y53S6ATLUIACT

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
a79dd0bd-9f96-70cf-e053-2a95a90a8366a79dd0bd-9f95-70cf-e053-2a95a90a83662020-06-08WarningsExact identifier
spl id: a79dd0bd-9f96-70cf-e053-2a95a90a8366
spl set id: a79dd0bd-9f95-70cf-e053-2a95a90a8366

Reported adverse events (FAERS/openFDA)#

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