Active Ingredient
Ethyl Alcohol 65% v/v.
Serene Clean And Pure Hand Sanitizer Gel
FDA Label NDC 78643-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Serene Clean & Pure Llc for the product Serene Clean And Pure Hand Sanitizer Gel (NDC 78643-300). 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 active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor, 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
Purpose
Antiseptic
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
When Using This Product
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor
if irritation or rash occurs. These may be signs of a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Water, glycerin, carbomer, aloe
Package Label - Principal Display Panel
Serene Clean & Pure
Be Wise & Sanitize
Gel Hand Sanitizer
www.serenepure.com
(424) 329-2515
ABOUT
Serene Clean & Pure is a family owned company that believes in honest and helpful products.
Serene Clean & Pure is a quickly drying hand sanitizer that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life
Manufactured by:
CALIFORNIA CHEMICAL
(424) 292-3424
Costa Mesa, CA 92626
www.calichemical.com
* Please review the disclaimer below.
