Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a6ceef4f-97a9-4dee-e053-2a95a90ab1ca
Route
TOPICAL
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Orange Oil Lavender Oil Alpha-tocopherol Glycerin Lemon Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-02

Description

Ethyl Alcohol 70%


Medication Information

Warnings and Precautions

For external use only

Flammable: Keep away from heat and flame

Indications and Usage

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

Dosage and Administration

* Wet hands thoroughly 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 right away.

Section 50566-9

* If irritation or rash occurs and persists for more than 72 hours.

Section 50567-7

* Keep out of eyes, ears, and mouth.

* In case of contact with eyes, rinse eyes thoroughly with water.

Section 50569-3

* If irritation or rash occurs and persists for more than 72 hours.

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions? 800.998.1762

Section 55105-1

Hand & Skin Antiseptic

Section 55106-9

Ethyl Alcohol 70%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

* Wet hands thoroughly 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 right away.

Section 50566-9 (50566-9)

* If irritation or rash occurs and persists for more than 72 hours.

Section 50567-7 (50567-7)

* Keep out of eyes, ears, and mouth.

* In case of contact with eyes, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)

* If irritation or rash occurs and persists for more than 72 hours.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions? 800.998.1762

Section 55105-1 (55105-1)

Hand & Skin Antiseptic

Section 55106-9 (55106-9)

Ethyl Alcohol 70%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)