Otc - Active Ingredient
Ethyl Alcohol 70% v/v.....Antibacterial Agent
70% Alcohol Hand Sanitizer
FDA Label NDC 50865-074
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kutol Products Company, Inc. for the product 70% Alcohol Hand Sanitizer (NDC 50865-074). 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 otc - active ingredient, inactive ingredient, otc - purpose, warnings, dosage & administration, indications & usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Triisopropanolamine
Otc - Purpose
For handwashing to help reduce bacteria on the skin
Warnings
For external use only.
Avoid contact with eyes. If eye contact occurs, flush eyes with water.
Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, contact a physician or poison control center.
Dosage & Administration
Apply to hair or body. Work into a rich lather. Massage hair and body completely for at least 30 seconds. Rinse thoroughly. Dry completely.
Indications & Usage
For handwashing to help reduce bacteria on the skin.
Avoid contact with eyes. If eye contact occurs, flush eyes with water.
Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, contact a physician or poison control center.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact a physician or poison control center.
Package Label.Principal Display Panel
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