Active Ingredient(S)
Ethyl Alcohol 75% v/v
Wash-free Hand Sanitizer
FDA Label NDC 55028-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhongshan Dermey Commodity Co., Ltd. for the product Wash-free Hand Sanitizer (NDC 55028-015). 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(s), purpose, use, warnings, do not use, otc - when using, 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
Purpose
Antiseptic
Use
Hand sanitizer to help decrease bacteria on the surface of skin.
Warnings
Flammable, Keep away from source of heat,fire or flame.
For external use only.
Do not apply around the eyes.
Do not use in ears & mouth.
Do Not Use
Do not apply around the eyes.
Do not use in ears & mouth.
Otc - When Using
When using this product
Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if
Irritation or redness develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Children must be supervised in use of this product.
Directions
Pump enough product into your plams and thoroughly spread on both hands, rub into skin until dry. Children under 6 years should be supervised when using this product.
Other Information
Store at temperature below 43°C (110°F)
Inactive Ingredients
Water, triethanolamine, glycerin, carbomer
* Please review the disclaimer below.
