Otc - Active Ingredient
Active Ingredient
Ethyl Alcohol 62%
Assured
FDA Label NDC 33992-4948
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International Inc. for the product Assured (NDC 33992-4948). 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 - keep out of reach of children, other, 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
Uses • hand sanitizer to help reduce bacteria on the skin •recommended for repeated use.
Warnings
Warnings •Flammable. • Keep away from fire and flame. •For external use only
Otc - When Using
When using this product •avoid contact with eyes • in case of eye contact immediately flush eyes with water, call a doctor • avoid contact with broken skin.
Discontinue use if irritation develops. If condition persists for more than 72 hours, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Children should only use this product under adult supervision. Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Other
Other information • do not store above 105F. May discolor some fabrics. • Harmful to wood finishes and plastics
Dosage & Administration
Directions • place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. • recommended for repeated use
Inactive Ingredient
Inactive ingredients aloe barbadensis gel, carbomer, fragrance, FD&C blue no. 1, FD&C yellow no.5, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, water
Package Label.Principal Display Panel
Label Image (Hndsntzraloe)
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