Active Ingredient
Ethyl Alcohol 70% v/v
Cleared For Take Off Hand Sanitizer
FDA Label NDC 83617-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Careeon Llc for the product Cleared For Take Off Hand Sanitizer (NDC 83617-001). 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, use(s), warnings, do not us, when using this product, stop us 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)
To kill bacteria on the skin that could cause disease. Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Us
on open skin wounds or children less than 2 months of age
When Using This Product
keep out of eyes. In case of contact with eyes, rinse thoroughly with water.
Stop Us And Ask A Doctor
if irritation or rash occurs or condition persists for more than 72 hours.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222
Directions
Dispense a dime-sized amount onto your hands or sufficient amount to cover area, and massage thoroughly until the product is absorbed. Supervise children under 6 years of age when using this product. Not recommended for infants.
Inactive Ingredients
Water (Aqua), Glycerin, Isopropyl Alcohol, Butylene Glycol, Lavandula Angustifolia (Lavender) Oil, Carbomer, Aminomethyl Propanol, Isopropyl Myristate, Linalool, Tocopheryl Acetate, Shea Butter Ethyl Esters, Sodium Ascorbyl Phosphate, Rosa Damascena Flower Extract, Geraniol, Limonene
Package Labeling:
Label (Label)
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