Otc - Active Ingredient
Active Ingredient:
Ethyl Alcohol 63%
Anti-bacterial Hand Sanitizer
FDA Label NDC 69583-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fun Zone, Inc. for the product Anti-bacterial Hand Sanitizer (NDC 69583-003). 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 - purpose, warnings, otc - stop use, dosage & administration, inactive ingredient, indications & usage, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Antiseptic
Warnings
Warnings:
For external use only. Flammable, keep away from fire, flame and direct sunlight.
Otc - Stop Use
Stop using this product and consult a doctor If irritation or redness develops.Stop using this product and consult a doctor If irritation or redness develops.
Dosage & Administration
Directions
- Rub dime sized amount between hands until dry.
- For use by children under 6 years, adult supervision is required.
Inactive Ingredient
Water, Propylene Glycol, Carbomer, Aminomethyl Propanol, Glycerin, Denotonium Benzoate
Indications & Usage
Uses To help reduce bacteria on hands.
Otc - When Using
When using this product Avoid contact with eyes and lips. If contact occurs, rinse with water.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.
Package Label.Principal Display Panel
Image Of Bottle Label (Fz)
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