Active Ingredients
Organic Ethyl Alcohol 80% v/v
Organic Antiseptic Gel Hand Sanitizer
FDA Label NDC 76598-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bioagaves De La Costa, S.a. De C.v. for the product Organic Antiseptic Gel Hand Sanitizer (NDC 76598-008). 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 ingredients, 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 reduce bacteria that can potencially 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.
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.
These may be signs of a serious condition.
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.
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 below 110F (43C)
- May discolor certain fabrics or surfaces
Inactive Ingredients
Organic aloe vera, glycerin, purified water
* Please review the disclaimer below.
