Otc - Active Ingredient
Ethyl Alcohol 70% v/v
Affex Care Hand Sanitizer
FDA Label NDC 79097-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Autotrol Corporation for the product Affex Care Hand Sanitizer (NDC 79097-023). 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, otc - purpose, indications & usage, warnings, instructions for use, otc - keep out of reach of children, other safety information, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Flammable. Keep away from heat or flame
For external use only.
Instructions For Use
place enough product in your palm to thoroughly cover your hands
rub hands together briskly until dry
children under 6 years of age should be supervised when using this product
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.
Other Safety Information
Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)
Dosage & Administration
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.
Otc - When Using
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a physician if skin irritation or rash develops.
Inactive Ingredient
Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate
Package Label.Principal Display Panel
3785 mL NDC: 79097-020-28
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