Aruba Aloe Hand Sanitizer Cream
FDA Label NDC 53675-213
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aruba Aloe Balm Nv for the product Aruba Aloe Hand Sanitizer (NDC 53675-213). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Alcohol 80.00% v/v
Purpose
Antiseptic
Uses
- Hand sanitizer to help reduce bacteria that potentially can cause disease.
- For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- On children less than 2 months of age
- On open skin wounds
When Using This Product
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor If
irritation or rash occurs. These may be signs of a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
Other Information
- Store between 15-30°C (59-86°F)
- Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients
Water (Aqua/Eau), Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Fragrance (Parfum), Citric Acid.
Package Labeling:
Label2 (Label2)
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