Otc - Active Ingredient
Active Ingredient[s] Purpose
Alcohol 80% v/v ................................. Anitseptic
Hand Sanitizer
FDA Label NDC 73785-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pernod Ricard Usa for the product Hand Sanitizer (NDC 73785-001). 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 otc - active ingredient, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, instructions for use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Warnings:
For External use only. Flammable. Keep away from heat and flame
Otc - Do Not Use
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 mounth. In case of contact with eyes flush 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.
Instructions For Use
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 40C (104F)
Inactive Ingredient
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
Indications & Usage
Use[s)
Hand Sanitizer to help reduce bacteria that potentially can cause disiease. For use when soap and water are not available.
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.
Otc - Purpose
Use[s)
Hand Sanitizer to help reduce bacteria that potentially can cause disiease. For use when soap and water are not available.
Package Label.Principal Display Panel
Smooth Ambler Version (Smoothamblerlabel)
Rabbit Hole (Rabbitholelabel)
Prhs (Pernodricardhsanitzer)
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