Active Ingredients
Alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 78426-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biobarrier360 Llc for the product Hand Sanitizer (NDC 78426-001). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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
Uses
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
- On 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 thoroughly with water.
Stop Use And Ask A Doctor If
- Stop use and seek 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, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone.
Questions?
call (877) 458-1315
Company Information
Distributed By:
BioBarrier360 LLC
Austin, TX 78758
www.BioBarrier360.com
Made in Guatemala
Product Packaging - 500 Ml
BIOBARRIER360
Hand Sanitizer
with moisturizing ingredients
Alcohol 70%
16.9 fl oz 500 ml
www.BioBarrier360.com
* Please review the disclaimer below.
