Active Ingredient(S)
Ethyl Alcohol 75%
Hand Sanitizer
FDA Label NDC 78414-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Caolvxiang Biotechnology Co.,ltd for the product Hand Sanitizer (NDC 78414-002). 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 active ingredient(s), purpose, use, warnings, do not use, when using section, stop use, 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 poterntially can cuase 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 rnonths of age
on open skin worunds
When Using Section
keep out of eyes.ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use
Stop use and ask a doctor if irritation or rash occurs.
These rnay be signs of a serious condition.
Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed. get medical help or contact a Posion Control Center right away.
Directions
Place enough product on hands to cover all surfaces, Rub hands together until dry.
Supervise clhildren under 6 years of age when using this product to avoid swallowing.
Other Information
Store between 15-30°C(59-86F)
Avoid freezing and excessive heat above 40°C(104F)
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
1 (1)
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