Active Ingredient(S)
Isopropyl Alcohol 70%
Hand Sanitizer
FDA Label NDC 80932-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roots Beauty Innovations Llc for the product Hand Sanitizer (NDC 80932-001). 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, directions, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Directions
- Place enough product on hands to cover all surfaces.
- Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Warnings
For external use only
Flammable. Keep away from heat or flame.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. Do not ingest. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Deionized Water, Glycerin, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Hydroxypropyl Cellulose, Limonene
Package Label - Principal Display Panel
60 ml NDC: 80932-001-06
* Please review the disclaimer below.
