Active Ingredient
Ethyl Alcohol 62%
Hydragen Pro Barrier Hand Sanitizer
FDA Label NDC 52205-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Skin Technology, Llc for the product Hydragen Pro Barrier Hand Sanitizer (NDC 52205-004). 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, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antispetic
Uses
- Hand Sanitizer to help reduce bacteria that potentially cause disease.
- For use when soap and water are not available.
Warnings
Flammable. Keep away from fire or flame.
For external use only.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do Not Use
- In children less than 2 months of age.
- On open skin wounds
Directions
- Place enough product in your palm to thoroughly cover your hands.
- Rub hands briskly until they are fully dry.
Other Information
- Store between 15-30°C (59-86°F).
- Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredients
Water, hydrolized jojoba esters, glycerin, PEG-10 dimethicone, sodium hyaluronate.
Package Label.Principal Display Panel
HydraGen
Pro Barrier Hand Sanitizer
with hyaluronic acid
5.7 fl. oz /168 ml
* Please review the disclaimer below.
