RAREESSENCE GEL WELL HAND SANITIZER- ethyl alcohol gel 
rareESSENCE, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Ethyl Alcohol 70%

Hand and Antiseptic

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

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

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

* Supervise children under 6 years of age

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

Questions? 800-998-1762

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

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RAREESSENCE GEL WELL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78035-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78035-002-0948 in 1 CARTON06/08/2020
1NDC:78035-002-0812 in 1 CASE
1NDC:78035-002-07118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:78035-002-1112 in 1 CARTON06/08/2020
2NDC:78035-002-10236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/08/2020
Labeler - rareESSENCE, LLC (011585557)
Registrant - rareESSENCE, LLC (011585557)
Establishment
NameAddressID/FEIBusiness Operations
Diversified Manufacturing Corporation185073996manufacture(78035-002) , pack(78035-002) , label(78035-002)

Revised: 6/2020
Document Id: a79dd0bd-9f96-70cf-e053-2a95a90a8366
Set id: a79dd0bd-9f95-70cf-e053-2a95a90a8366
Version: 1
Effective Time: 20200608
 
rareESSENCE, LLC