Active Ingredients
Ethyl alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 80535-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacia San Arcangel, S.a De C.v for the product Hand Sanitizer (NDC 80535-0002). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available
Warnings
For external use only . flammable - keep away from heat or flame
Do Not Use
In children less than 2 months of age - on open skin wounds
When Using This Product
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throrugly with water
Stop Use And Ask A Doctor
if irritation or rash occurs. These maybe signs of a serious condition.
Keep Out Of Reach Of Children
if swallowed, get medical help or contact a poison control center right away.
Directions
Put 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
Other Information
Store between 15-30C (58-86F)
Avoid freezing and excesive heat above 40C (104F)
Inactive Ingredients
Water (aqua), Vegetable Glycerine UPC, Hudroxypropyl methylcellulose and carboxymethylcellulose.
Principal Display
Hand sanitizer
70% alcohol
68 fl. oz. (2.1qt) (2L)
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