Otc - Active Ingredient
Ethanol 70%
Hand Sanitizer
FDA Label NDC 65692-2072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc for the product Hand Sanitizer (NDC 65692-2072). 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 - keep out of reach of children, dosage & administration, 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 - Purpose
Antimicrobial
Indications & Usage
Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use.
Warnings
Warnings• For external use only
• Flammable, keep away from fire or flame
• Do not use in eyes. In case of eye contact flush
thoroughly with water and seek medical attention.
• Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
• Dispense an adequate amount in your palm to cover all surfaces of hands completely.
• Rub hands together until dry. • Does not require rinsing.
Other Safety Information
Other Information
• Do not store above 105°F.
• May discolor some fabrics.
Inactive Ingredient
Inactive Ingredients: Water (Aqua), Isopropyl Alcohol, Orange Oil, Acrylates/C10-30 Akyl Acrylate Crosspolymer, Glycerin, Aloe Barbadensis Leaf Juice, Panthenol, Aminomethyl Propanol.
* Please review the disclaimer below.
