Active Ingredient(S)
Alcohol 80% v/v Purpose: Antiseptic
Emely Hand Sanitizer
FDA Label NDC 77998-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios E&m Srl for the product Emely Hand Sanitizer (NDC 77998-001). 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 active ingredient(s), purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Aseptic, Hand Sanitizer
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
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
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)
Inactive Ingredients
Glicerin, Purified Water USP, Triethanolamine, Carbomer
Package Label - Principal Display Panel
60 mL NDC: 77998-001-10
120 mL NDC: 77998-001-20
240 mL NDC: 77998-001-30
480 mL NDC: 77998-001-40
960 mL NDC: 77998-001-50
1920 mL NDC: 77998-001-60
3785 mL NDC: 77998-001-70
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