RAREESSENCE GEL WELL HAND SANITIZER- ethyl alcohol gel

rareEssence Gel Well Hand Sanitizer by

Drug Labeling and Warnings

rareEssence Gel Well 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 and Antiseptic

INDICATIONS & USAGE

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

WARNINGS

For external use only

Flammable: Keep away from heat and flame

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

* Do not ingest or inhale

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

* If irritation or redness develops

* Have open wounds or serious burns

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

DOSAGE & ADMINISTRATION

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

* Supervise children under 6 years of age

INACTIVE INGREDIENT

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

QUESTIONS

Questions? 800-998-1762

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

INGREDIENTS AND APPEARANCE

RAREESSENCE GEL WELL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78035-002
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
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CARBOMER 940 (UNII: 4Q93RCW27E)
ORANGE OIL (UNII: AKN3KSD11B)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDIN OIL (UNII: 9RES347CKG)
WATER (UNII: 059QF0KO0R)
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78035-002-09	48 in 1 CARTON	06/08/2020
1	NDC: 78035-002-08	12 in 1 CASE
1	NDC: 78035-002-07	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 78035-002-11	12 in 1 CARTON	06/08/2020
2	NDC: 78035-002-10	236 mL in 1 BOTTLE, PUMP; 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	06/08/2020

Labeler - rareESSENCE, LLC (011585557)

Registrant - rareESSENCE, LLC (011585557)

Establishment
Name	Address	ID/FEI	Business Operations
Diversified Manufacturing Corporation		185073996	manufacture(78035-002) , pack(78035-002) , label(78035-002)