Otc - Active Ingredient
Alcohol 75% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 80017-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Broder Bros Prime Line for the product Hand Sanitizer (NDC 80017-001). 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, uses, warnings, when using this product, otc - stop use, inactive ingredient, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic, Hand Sanitizer
Uses
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when water are not available.
Warnings
Flammable, keep away from fire and flame
For external use only
When Using This Product
Keep out of eyes
In case of contact with eyes, flush thoroughly with water.
Avoid contact with broken skin.
Do not inhale or ingest.
Otc - Stop Use
Stop use and ask a doctor if irritation and redness develops and persists for more than 72 hours.
Inactive Ingredient
Water, Glycerin, Triethanolamine, Carbomer
Directions
Wet hands thoroughly with product, brisky rub together until dry.
Always supervise children in the use of this product.
Children under the age of 6 months: Ask a doctor.
Other Safety Information
Store at 66 to 77 F (22 to 25 C)
May discolor some fabrics
Harmful to wood finishes and platics
Otc - Keep Out Of Reach Of Children
Keep our of reach of Children. If swallowed, get medical help or call a Poison Control Center right away.
Package Label - Principal Display Panel
5 mL NDC: 80017-001-01
Pdp (80017 001 01)
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