Hand Sanitizer
FDA Label NDC 50157-569
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brands International for the product Hand Sanitizer (NDC 50157-569). 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 drug facts, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Ethyl alcohol 62%.
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
For handwashing to decrease bacteria on the skin.
Warnings
Warnings
Flammable, keep away from fire or flame.For external use only.
When using this product Avoid contact with eyes. In case of contact flush eyes with water.
Stop use and ask a doctor If redness or irritation develop and persist for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Spread on both hands, rub in, let dry.
Inactive Ingredient
Inactive Ingredients Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water, Isopropyl Myristate, Aminomethyl Propanol.
Please review individual labels for specific details on colors and additives on 3 different variety of sanitizers.
Packaging
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