RAREESSENCE HAND SANITIZER- ethyl alcohol liquid

rareESSENCE Hand Sanitizer by

Drug Labeling and Warnings

rareESSENCE Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by rareESSENCE, LLC, Diversified Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 70%

PURPOSE

Hand & Skin Antiseptic

INDICATIONS & USAGE

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin

WARNINGS

For external use only

Flammable: Keep away from heat and flame

* Keep out of eyes, ears, and mouth.

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

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

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

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

DOSAGE & ADMINISTRATION

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

* Supervise children under 6 years of age.

INACTIVE INGREDIENT

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

QUESTIONS

Questions? 800.998.1762

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

INGREDIENTS AND APPEARANCE

RAREESSENCE HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78035-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ORANGE OIL (UNII: AKN3KSD11B)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERIN (UNII: PDC6A3C0OX)
LEMON OIL (UNII: I9GRO824LL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78035-001-03	48 in 1 CARTON	06/02/2020
1	NDC: 78035-001-02	12 in 1 CASE
1	NDC: 78035-001-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 78035-001-06	48 in 1 CARTON	06/02/2020
2	NDC: 78035-001-05	12 in 1 CASE
2	NDC: 78035-001-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020

Labeler - rareESSENCE, LLC (011585557)

Registrant - rareESSENCE, LLC (011585557)

Establishment
Name	Address	ID/FEI	Business Operations
Diversified Manufacturing Corporation		185073996	manufacture(78035-001) , pack(78035-001) , repack(78035-001) , label(78035-001)