Active Ingredient
Alcohol 70% v/v
O2 Clean Hand Sanitizer
FDA Label NDC 80453-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O2 Clean for the product O2 Clean Hand Sanitizer (NDC 80453-010). 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, inactive ingredients, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Acorus Calamus Root Extract, Camellia Sinensis Leaf Extract, Carbomer, Citrus Paradisi (Grapefruit) Fruit Extract, Cnidium Officinale Rhizome Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Oil, Morus Alba Bark Extract, Sophora Angustifolia Root Extract, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, Water
Purpose
Hand Sanitizer
Warnings
For external use only.
Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses
Can be used anytime and has effective Sterilization
Directions
• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
• Supervise children in the use of this product.
Other Information
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
* Keep out of direct light and store in a cool, dry area
* Please review the disclaimer below.
