Otc - Active Ingredient
Active Ingredient [s] Purpose
Alcohol 80% v/v.......................................Antiseptic
Vydal Scented Hand Sanitizer
FDA Label NDC 74563-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by List Distillery, Llc for the product Vydal Scented Hand Sanitizer (NDC 74563-003). 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 - do not use, otc - keep out of reach of children, otc - ask doctor, warnings, otc - when using, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Do Not Use
Do not use
- In children under 2 months of age.
- On open wounds.
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.
Otc - Ask Doctor
Stop use and ask a doctor if rash or irritation occurs, this may be sign of a serious condition.
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
Other Safety Information
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Inactive Ingredients
Gylcerin, Hydrogen Peroxide, Purified Water USP.
Dosage & Administration
Directions
- Place enough product on hands to cover entire surface.
- Rub hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Indications & Usage
Use [s]
Hand sanitizer helps reduce bacteria that potentially causes disease. For use when soap and water are not available.
Otc - Purpose
Use [s]
- Hand sanitizer helps reduce bacteria that potentially causes disease.
- For use when soap and water are not available.
Package Label.Principal Display Panel
Mr. Tom's
Estd 2015
Hand Sanitizer
Alcohol Antiseptic 80%
Topical Solution
WHO Rocommended Hand Rub
Formulation #1
For External Use Only
Not Safe or Consumption
Non-Sterile Solution
Net Wt.: 1.01 FL OZ
(30 ML)
* Please review the disclaimer below.
