RareEssence Gel Well Hand Sanitizer: Package Insert and Label Information

RAREESSENCE GEL WELL HAND SANITIZER- 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.

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

Gel Well Hand sanitizer 12x8oz
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Gel Well Hand sanitizer 48x4oz
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Gel Well Hand sanitizer 12x4oz
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Gel Well Hand sanitizer 4oz
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALPHA-TOCOPHEROL
CARBOMER 940
ORANGE OIL
LAVENDER OIL
LAVANDIN OIL
WATER
LEMON OIL
GLYCERIN
DIMETHICONE 350
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78035-002-09 48 CASE in 1 CARTON contains a CASE (78035-002-08)
1 NDC:78035-002-08 12 BOTTLE, PLASTIC in 1 CASE This package is contained within the CARTON (78035-002-09) and contains a BOTTLE, PLASTIC (78035-002-07)
1 NDC:78035-002-07 118 mL in 1 BOTTLE, PLASTIC This package is contained within a CASE (78035-002-08) and a CARTON (78035-002-09)
2 NDC:78035-002-11 12 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP (78035-002-10)
2 NDC:78035-002-10 236 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (78035-002-11)
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 Operations
Diversified Manufacturing Corporation 185073996 manufacture (78035-002), pack (78035-002), label (78035-002)

Revised: 06/2020 rareESSENCE, LLC

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