Otc - Active Ingredient
Alcohol 75 % v/v
Hand Sanitizer
FDA Label NDC 74013-444
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Charta Group Inc Dba Permalite Inc for the product Hand Sanitizer (NDC 74013-444). 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, otc - do not use, otc - stop use, otc - keep out of reach of children, 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
For external use only. Flammable. Keep away from heat or flame
Otc - Do Not Use
- in children less than 2 months of age
- on open skin wounds
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.
Dosage & 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.
Other Safety Information
Other Information:
Store between 15-30c (59-86F)
Avoid freezing and excessive heat above 40 C (104F)
Inactive Ingredient
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
Hand Sanitizer
Hand Sanitizer (Label)
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