Active Ingredient
Alcohol 75% v/v.
Premium Hand Sanitrizer
FDA Label NDC 78620-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Port Royal Sales, Ltd. for the product Premium Hand Sanitrizer (NDC 78620-001). 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, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
• Hand sanitizer to help decrease bacteria on the skin when soap and towel are not available. • Recommended for repeated use
Warnings
For external use only. Flammable. Keep away from heat or flame • Do not apply around eyes • Do not use in ears or mouth
When Using This Product
avoid contact eith eyes. In case of eye contact flush eyes with water
Stop Use And Ask A Doctor If
redness or irritation develops and persists for more than 72 hours.
Keep Out Of Reach Of Children
Children must be supervised in use of this product.
Directions
Place enough product into your palms and thoroughly spread on both hands. • Rub into skin until dry.
Other Information
Store below 110°F (43°C). May discolor certain surfaces.
Inactive Ingredients
Carbomer, triethanolamine, glycerine, water.
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