The following Structured Product Label (SPL) was submitted to the FDA by Fareva Morton Grove, Inc. for the product Hand Sanitizer (NDC 72686-187). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerin
c. FRAGRANCE (PARFUM)
d. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
e. ALOE BARBADENSIS LEAF JUICE
f. AMINOMETHYL PROPANOL
g. YELLOW 5 (CI 19140)
h. CITRIC ACID
i. SODIUM BENZOATE
j. POTASSIUM SORBATE
Alcohol 78% v/v. Purpose: Antiseptic
Antiseptic
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
For external use only. Flammable. Keep away from heat or flame
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 and redness develops and persists.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Citric Acid, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Water, Yellow 5 (CI 19140)
50 mL NDC: 72686-187-05
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