Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antimicrobial
Hand Sanitizer
FDA Label NDC 78046-1121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hill & Markes for the product Hand Sanitizer (NDC 78046-1121). 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 active ingredient(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use
Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.
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 eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
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.
Directions
Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry.
No rinsing required. No towels needed.
Inactive Ingredients
Water (Aqua), Aloe Vera, Propylene Glycol, Carboxethyl Acrylate Crosspolymer, FD&C Blue #1, FD&C Yellow #5
Description
Hand Sanitizer Gel
Moisturizing with Aloe
Effective at eliminating more than 99.9% of many common harmful germs & bacteria in as little as 15 seconds.
Package Label - Principal Display Panel
118.29 mL NDC: 78046-1124-1
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