Mcl Hand Sanitizer
FDA Label NDC 80411-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Midcontinental Compounding Laboratory Llc for the product Mcl Hand Sanitizer (NDC 80411-001). 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, active ingredients[s}, purpose, use[s], warnings, directions, other information, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients[S}
Alcohol 80%
Purpose
Antiseptic
Use[S]
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 eyes, rinse thoroughly with water.
Stop useand ask doctor if irritation or rash occurs. There may be signs of a serious condition.
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
Other Information
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
Packaging
Image (80411001 16)
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