Active Ingredient[S]
Alcohol 80% v/v
Alcohol Antiseptic Hand Sanitizer Non-sterile Solution
FDA Label NDC 80095-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pegasus Biotechnology Llc. for the product Alcohol Antiseptic Hand Sanitizer Non-sterile Solution (NDC 80095-000). 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[s], warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of chilren., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use[S]
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
- in 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 eyes thoroughly with water.
Stop Use And Ask A Doctor
if irritation or rash occurs. These may be signs of a serious condition.
Keep Out Of Reach Of Chilren.
If swallowed, get medical help or contact a Poison Control Center
Directions
• Place enough product on hands to cover all surfaces. Rub hands together continuously 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
Aloe Vera, Vitamin E, Carbomer, TEA, Deionized Water, Fragrance, fd&c blue no.1
Package Labeling:50 Ml
Label (Label)
Package Labeling:100 Ml
Label2 (Label2)
Package Labeling:250 Ml
Label3 (Label3)
Package Labeling:500 Ml
Label.4 (Label.4)
Package Labeling: 1000
Label5 (Label5)
* Please review the disclaimer below.
