Active Ingredient
Ethanol 90.24%
Ossion Hand Sanitizer
FDA Label NDC 77462-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sora Kozmetik Sanayi Ticaret Anonim Sirketi for the product Ossion Hand Sanitizer (NDC 77462-002). 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 active ingredient, purpose, use, warnings, otc - stop use, otc - when using, 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
Use
It is used for local disinfection of hands and skin. It is effective against microbes and bacteria. It provides easiness and hygiene in at home, at work, in crowded environments.
Warnings
For external use only.
DANGER: Flammable. Contents Under Pressure.
Do not use near heat, sparks, or flames. Vapors may ignite explosively & cause flash fire. Prevent build-up of vapors. Do not smoke. Turn off pilot light, stoves, heaters, and other sources of ignition during use and until all vapors are gone. Do not puncture or incinerate container. Do not expose to heat or store at temperatures about 120F. Use with adequate ventilation.
Otc - Stop Use
Stop use and ask a doctor if irritation and redness develops.
Otc - When Using
Avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical attention.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Keep out of reach of children and pets: Children under 6 years age should be supervised by an adult when using. If swallowed, get medical help or contact your Poison Control Center right away.
Directions
Take a suffiicent amount in your palm and spread over the entirety of your hand and fingers. Wait for about 30 seconds for your hands to dry.
Other Information
Store at room temperature or in a cool place.
Inactive Ingredients
Water, Panthenol (Vitamin B5), Glycerol, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis (Aloe Vera) Leaf Juice.
Package Label - Principal Display Panel
Ossion (Ossion)
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