Otc - Active Ingredient
Active ingredient
Ethyl Alcohol 70% v/v
Rio Glow Hand Sanitizer Liquid
FDA Label NDC 87361-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peach Layne, Llc for the product Rio Glow Hand Sanitizer (NDC 87361-002). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Use [s]
Hand sanitizer to reduce bacteria on the skin. Recommended for repeated use.
Warnings
Warnings
For external use only. Flammable, keep away form fire or flame.
May Cause Serious Irritation In Case of Direct Eye Contact.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not use on broken or irritated skin.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops and lasts more than 72 hours.
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
Spray enough product in your palm to thoroughly cover hands. Rub hands together briskly until dry. Children under 6 years should be supervised when using this product.
Storage And Handling
Other information
· Store below 104 ℉ (40 ℃).
· Avoid excessive heat or direct sunlight.
· May discolor certain fabrics.
Inactive Ingredient
Inactive Ingredients
Water (Aqua), Glycerin, Fragrance(parfum), Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (VITAMIN E), Benzyl Alcohol, Benzyl Benzoate, Benzyl Salicylate, Coumarin, Hydroxycitronellal, Limonene, Linalool, Rose Ketones, Benzaldehyde, Hexamethylindanopyran, Tetramethyl Acetyloctahydronaphthalenes, Vanillin.
Package Label.Principal Display Panel
Rio Glow Hand Sanitizer
NDC: 87361-002-01
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