Otc - Active Ingredient
Active ingredient Purpose
Ethyl Alcohol 66.5% v/v....................Antiseptic
Hand Sanitizer
FDA Label NDC 55550-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Total Resources International Inc. for the product Hand Sanitizer (NDC 55550-108). 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 - do not use, otc - stop use, otc - keep out of reach of children, indications & usage, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use: For handwashing to decrease bacteria on skin without soap and water.
Warnings
Warnings For external use only
Flammable, keep away from fire or flame
Otc - Do Not Use
Do not use •in the eyes if happens, rinse thoroughly with water.
Otc - Stop Use
Stop use, ask a doctor if irritation develops and persists for 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.
Indications & Usage
Directions wet hands and wrists thoroughly with product and allow to dry without wiping supervise children while using this product
Other Safety Information
Other Information store at room temperature 59°- 86°F ( 15°- 30°C )
Inactive Ingredient
Inactive ingredient aloe vera*, carbomer*, D&C green #5*, D&C yellow #10*, fragrance *, triethanolamine*, water* may contain
Otc - Questions
Questions? Call 1-888-771-7824
Dosage & Administration
For External Use Only
Hand Sanitizer
* Please review the disclaimer below.
