Active Ingredient
Ethyl alcohol 70% v/v
Onyx Advanced Hand Sanitizer
FDA Label NDC 75403-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Onyx Premiere Llc for the product Onyx Advanced Hand Sanitizer (NDC 75403-000). 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, purpose, use:, warnings, do not, keep out of reach of children., directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Use:
Hand sanitizer to help reduce bacteria on the skin.
Warnings
Flammable. Keep away from fire or flame. For external use only.
Do Not
ingest, if swallowed seek medical help. Avoid contact with eyes.
Keep Out Of Reach Of Children.
Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.
Directions:
Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.
Other Information:
Store below 106°F (41°C).
May discolor certain fabrics or surfaces.
Inactive Ingredients:
demineralized water, glycerin, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.
Package Labeling:
Label (Label)
* Please review the disclaimer below.
