Otc - Active Ingredient
Ethanol 70.0% (w/w)
(equivalent to 76.91% v/v)
Aniosgel 85 Gel
FDA Label NDC 62169-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Anios for the product Aniosgel 85 (NDC 62169-203). 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, recent major changes, warnings, otc - do not use, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic Hand Rub
Indications & Usage
• A hand rub to decrease bacteria on the skin.
Recent Major Changes
Uses
• A hand rub to decrease bacteria on the skin.
Warnings
Warnings
• For external use only
• FLAMMABLE. Keep away from fire or flame, heat
sparks and sources of static discharge.
Otc - Do Not Use
In eyes
Otc - When Using
When using this product
• If in eyes, rinse promptly and thoroughly with water.
• Discontinue use if irritation and redness develop.
Otc - Ask Doctor
Stop use and ask a doctor if skin irritation or redness occurs for
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
Apply product onto hands, spread thoroughly and rub until dry.
Other Safety Information
Other information
• Store at 41 - 77 °F (5 - 25 °C)
• See Safety Data Sheet (SDS)
• For emergency medical information in USA, call (800)726-2308
Inactive Ingredient
Inactive ingredients
Water (aqua), Isopropyl Alcohol, Glycerin, Acrylates/C10-30
Alkyl Acrylate Cross-polymer, PEG-5 Cocoate, Bisabolol,
Aminomethyl Propanol, Methylpropanediol
Otc - Questions
Questions or comments?
Call (800)726-2308 Monday/Friday 9:00am to 5:00pm
Package Label.Principal Display Panel
Aniosgel85npc_backpanel.jpg (Aniosgel85npc Backpanel)
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