Active Ingredient
Active ingredient Ethyl Alcohol 70%
Hand Sanitizer
FDA Label NDC 78349-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biozone Chemical, S. De R.l. De C.v. for the product Hand Sanitizer (NDC 78349-0002). 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, dosage and administration, inactive ingredients, indications and usage, keep out of reach of children, purpose, warnings, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage And Administration
Directions
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive Ingredients
Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine
Indications And Usage
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Keep Out Of Reach Of Children
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.
Purpose
Purpose Antmicrobial
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame
Warnings And Precautions
Warnings
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 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.
Ask Doctor
Stop use and ask a doctor if irritation or rash occurs
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