RareESSENCE Hand Sanitizer: Package Insert and Label Information

RAREESSENCE HAND SANITIZER- alcohol liquid
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 & Skin Antiseptic

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

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.

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

* Supervise children under 6 years of age.

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

Questions? 800.998.1762

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 48x4oz
(click image for full-size original)
Spray It Away Hand Sanitizer 48x2oz
(click image for full-size original)
Spray It Away Hand Sanitizer 12x4oz
(click image for full-size original)
Spray It Away Hand Sanitizer 12x2oz
(click image for full-size original)
Spray It Away Hand Sanitizer 4oz
(click image for full-size original)
Spray It Away Hand Sanitizer 2oz
(click image for full-size original)
RAREESSENCE HAND SANITIZER
ethyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78035-001
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
WATER
ORANGE OIL
LAVENDER OIL
ALPHA-TOCOPHEROL
GLYCERIN
LEMON OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78035-001-03 48 CASE in 1 CARTON contains a CASE (78035-001-02)
1 NDC:78035-001-02 12 BOTTLE, SPRAY in 1 CASE This package is contained within the CARTON (78035-001-03) and contains a BOTTLE, SPRAY (78035-001-01)
1 NDC:78035-001-01 59 mL in 1 BOTTLE, SPRAY This package is contained within a CASE (78035-001-02) and a CARTON (78035-001-03)
2 NDC:78035-001-06 48 CASE in 1 CARTON contains a CASE (78035-001-05)
2 NDC:78035-001-05 12 BOTTLE, SPRAY in 1 CASE This package is contained within the CARTON (78035-001-06) and contains a BOTTLE, SPRAY (78035-001-04)
2 NDC:78035-001-04 118 mL in 1 BOTTLE, SPRAY This package is contained within a CASE (78035-001-05) and a CARTON (78035-001-06)
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 Operations
Diversified Manufacturing Corporation 185073996 manufacture (78035-001), pack (78035-001), repack (78035-001), label (78035-001)

Revised: 06/2020 rareESSENCE, LLC

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