Otc - Active Ingredient
Ethyl Alcohol 70%
Rareessence Gel Well Hand Sanitizer
FDA Label NDC 78035-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rareessence, Llc for the product Rareessence Gel Well Hand Sanitizer (NDC 78035-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hand and Antiseptic
Indications & Usage
Hand and skin antiseptic to help decrease pathogens (germs) on the skin
Warnings
For external use only
Flammable: Keep away from heat and flame
Otc - When Using
* Avoid contact with eyes. If contact occurs flush eyes thoroughly with clean and cold water
* Do not ingest or inhale
Otc - Ask Doctor
* If irritation or redness develops, and/or you have open wounds or serious burns.
Otc - Stop Use
* If irritation or redness develops
* Have open wounds or serious burns
Otc - Keep Out Of Reach Of Children
* If swallowed get medical help or contact a Poison Control Center immediately
Dosage & Administration
* Wet hands thourhgly with product and allow to dry without wiping
* Supervise children under 6 years of age
Inactive Ingredient
Purified water, Glycerin, Orange Oil, Lemon Oil, Lavender Oil, Lavandin Oil, Vitamin E, Carbomer, Dimethicone, Aminomethyl Propanol
Otc - Questions
Questions? 800-998-1762
Package Label.Principal Display Panel
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
* Please review the disclaimer below.
