Otc - Active Ingredient
Active Ingredient
Ethanol 63% v/v
Tazza-x Extreme 63% Alcohol Formula Hand Sanitizing Gel
FDA Label NDC 76370-0034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tazza Brands East Inc. for the product Tazza-x Extreme 63% Alcohol Formula Hand Sanitizing (NDC 76370-0034). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses Decreases bacteria on hands
Warnings
Warnings
· Flammable: Keep away from flame or high heat.
· For external use only.
· When using this product keep out of eyes. Stop use and ask a
doctor if redness or irritation develops.
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.
Dosage & Administration
Directions
· Dispense an adequate amount in your palm
to cover all surfaces of both hands completely.
· Rub hands together until dry.
Inactive Ingredient
Inactive Ingredients
Purified Water, Glycerin, Triethanolamine,
Carbomer, Vitamin E, Aloe Vera.
Package Label.Principal Display Panel
NET 16.9 FL. OZ.
(500ML)
NDC: 76370-0034-0
* Please review the disclaimer below.
