Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a79dd0bd-9f95-70cf-e053-2a95a90a8366
Route
TOPICAL
Published
Effective Date 2020-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Alpha-tocopherol Carbomer 940 Orange Oil Lavender Oil Lavandin Oil Water Lemon Oil Glycerin Dimethicone 350

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-08

Description

Ethyl Alcohol 70%


Medication Information

Warnings and Precautions

For external use only

Flammable: Keep away from heat and flame

Indications and Usage

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

Dosage and Administration

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

* Supervise children under 6 years of age

Description

Ethyl Alcohol 70%

Section 50565-1

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

Section 50566-9

* If irritation or redness develops

* Have open wounds or serious burns

Section 50567-7

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

* Do not ingest or inhale

Section 50569-3

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

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions? 800-998-1762

Section 55105-1

Hand and Antiseptic

Section 55106-9

Ethyl Alcohol 70%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

* Supervise children under 6 years of age

Warnings and Precautions (34071-1)

For external use only

Flammable: Keep away from heat and flame

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

* If irritation or redness develops

* Have open wounds or serious burns

Section 50567-7 (50567-7)

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

* Do not ingest or inhale

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions? 800-998-1762

Section 55105-1 (55105-1)

Hand and Antiseptic

Section 55106-9 (55106-9)

Ethyl Alcohol 70%


Advanced Ingredient Data


Raw Label Data

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