Active Ingredient
Ethyl Alcohol 70%
Hand Sanitizer Gel
FDA Label NDC 80228-2001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Synergetics, Inc for the product Hand Sanitizer (NDC 80228-2001). 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, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Uses
Hand sanitizer to help reduce bacteria on skin.
Warnings
Flammable -For external use only - Avoid eye contact. If in the eyes flush with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash develops and lasts
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children - If swallowed get medical help or call a Poison Control Center right away.
Directions
Put enough in palm to cover hands - Rub hands briskly until dry. - Children under 6 years of age should be supervised when using this product.
Inactive Ingredients
Water(Aqua) Alicyle Acrylate, Crosspolymer, Aminomethyl Propanol, Caprylyl Glycol, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Fragrance, Tocopherol Acetate
Otc - Questions
Questions: 833-523-1109
Other Information:
Store below 110° F (43°C) May discolor certain fabrics and surfaces
Principal Display Panel - 1.2 Ml Pouch Label
TEAR
HERE
Universal
Synergetics Rx
ADVANCED
HAND
SANITIZER
GEL WITH
MOISTURIZERS
Compare to Purell*
Kills 99.99% of
Most Common Germs
Which May Cause Illness.
Contains 70% Ethanol
FDA Registered
★ Made in USA ★
1.2 mL (.04 fl oz.)
Principal Display Panel (1.2 mL Pouch Label)
* Please review the disclaimer below.
