Active Ingredients
Ethyl Alcohol 80% v/v
Fresh Protect Hand Sanitizer
FDA Label NDC 69243-0110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Willspeed Technologies Llc for the product Fresh Protect Hand Sanitizer (NDC 69243-0110). 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 ingredients, purpose, uses, 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
Antimicrobial
Uses
- hand sanitizing to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Do not drink.
Flammable. Keep away from heat and flame
Do Not Use
on children less than 2 years 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 - supervised children under 6 years of age when using this product to avoid swallowing.
Other Information
- store at 15C to 30C (59F to 86F) - Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Water, Ammonium Acryloyldimethltaurate/VP Copolymer, Citrus Sinensis Peel Oil expressed, Citrus Aurantium Bergamia (Bergamot Peel Oil, Citrus Aurantifolia (Lime) Oil, Aloe Barbadensis Leaf Juice, Niacinamide, Hydrogen Peroxide, Maltodextrin, Tocopheryl Acetate, DL-Panthenol
Principal Display Panel
Fresh
PROTECT
HAND SANITIZER GEL
80% ALCOHOL
Non-sterile solution
Principal Display Panelfreshprotecthand Sanitizer Gel80% Alcoholnon-sterile Solution (Fresh Protect Gel Scented Pump 01)
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