Active Ingredient[S]
Isopropyl alcohol 70% v/v
Advanced Hand Sanitizer
FDA Label NDC 79987-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yugen Pharmaceuticals, Llc for the product Advanced Hand Sanitizer (NDC 79987-201). 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 children., 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 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
glycerin, hydrogen peroxide, purified water USP
Company Information
YUGEN PHARMACEUTICALS
122 W 27th Street, 11th Floor
New York, NY 10001
Product Packaging - 250 Ml
Yugen PHARMACEUTICALS
ADVANCED
HAND SANITIZER
ALCOHOL 70% GEL FORMULA
Helps Kill Germs
Moisturizing
Unscented
MADE IN U.S.A.
USP GRADE
8.5 FL OZ / 250 ML
Yugen (Yugen)
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