FDA.reportPublic FDA data

rareESSENCE Hand Sanitizer

Manufacturer
rareESSENCE, LLC | Diversified Manufacturing Corporation
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:47

Label at a glance#

ProductrareESSENCE Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Hand & Skin Antiseptic

INDICATIONS & USAGE SECTION

Hand & 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

* Keep out of eyes, ears, and mouth.

* In case of contact with eyes, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

* If irritation or rash occurs and persists for more than 72 hours.

OTC - STOP USE SECTION

* If irritation or rash occurs and persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

* If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

* Wet hands thoroughly with product and allow to dry without wiping.

* Supervise children under 6 years of age.

INACTIVE INGREDIENT SECTION

Purified water, Vegetable Glycerin, Organic orange oil, Organic French Lavender oil, Organic Lavandin oil, Organic Lemon Oil, Vitamin E

OTC - QUESTIONS SECTION

Questions? 800.998.1762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

rareESSENCE AROMATHERAPY

Spray It Away (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 Frangrances

No Phthalates

No Parabens

Reduceds Germs that can potentially cause disease

Washing hands with soap and warm water remains the best way to remove germs. For use when souap and water are not available.

Made in USA

rareEssence, LLC

Minneapolis, MN 55344

www.rareEssenccearomatherapy.com

xx oz (zzzmL) NDC 78035-001-xx

Spray It Away Hand Sanitizer 48x4ozSpray It Away Hand Sanitizer 48x4oz

Spray It Away Hand Sanitizer 48x2ozSpray It Away Hand Sanitizer 48x2oz

Spray It Away Hand Sanitizer 12x4ozSpray It Away Hand Sanitizer 12x4oz

Spray It Away Hand Sanitizer 12x2ozSpray It Away Hand Sanitizer 12x2oz

Spray It Away Hand Sanitizer 4ozSpray It Away Hand Sanitizer 4oz

Spray It Away Hand Sanitizer 2ozSpray It Away Hand Sanitizer 2oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78035-001-032023-01-30C16284748780-1f386c649-a5cf-0266-e053-dadaa90a7c1aDrug Facts
78035-001-062023-01-30C16284748780-1f386c649-a5cf-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78035-001-01rareESSENCE Hand Sanitizer59 mL in 1 BOTTLE, SPRAYLIQUID591
78035-001-02rareESSENCE Hand Sanitizer12 in 1 CASELIQUID121
78035-001-03rareESSENCE Hand Sanitizer48 in 1 CARTONLIQUID481
78035-001-04rareESSENCE Hand Sanitizer118 mL in 1 BOTTLE, SPRAYLIQUID1181
78035-001-05rareESSENCE Hand Sanitizer12 in 1 CASELIQUID121
78035-001-06rareESSENCE Hand Sanitizer48 in 1 CARTONLIQUID481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78035-001RAREESSENCE HAND SANITIZER (ETHYL ALCOHOL) LIQUID [RAREESSENCE, LLC]1Legacy NDC, 6 package rows20200603_a6ceef4f-97a9-4dee-e053-2a95a90ab1ca.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78035-00178035-001-01, 78035-001-02, 78035-001-03, 78035-001-04, 78035-001-05, 78035-001-06

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ORANGE OILAKN3KSD11BIACT
LAVENDER OILZBP1YXW0H8IACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
GLYCERINPDC6A3C0OXIACT
LEMON OILI9GRO824LLIACT

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
a6ceef4f-97aa-4dee-e053-2a95a90ab1caa6ceef4f-97a9-4dee-e053-2a95a90ab1ca2020-06-02WarningsExact identifier
spl id: a6ceef4f-97aa-4dee-e053-2a95a90ab1ca
spl set id: a6ceef4f-97a9-4dee-e053-2a95a90ab1ca

Reported adverse events (FAERS/openFDA)#

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