Active Ingredient
Benzalkonium Chloride 0.1%
Summit 367 Antibacterial Foam Solution
FDA Label NDC 23590-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by R.l. Williams Company for the product Summit 367 Antibacterial Foam (NDC 23590-200). 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 - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antibacterial
Use
For hand washing to help reduce bacteria on the skin
Warnings
For external use only.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists 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.
Directions
- Pump a small amount of foam into palm of hand.
- Scrub thoroughly for at least 15 seconds.
- Rinse completely and dry.
Inactive Ingredients
Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Fragrance, Citric Acid, Red 40, Blue 1
Package Label.Principal Display Panel
Product Label (850 mL Cartridge (Front))
Product Label (850 mL Cartridge (Back))
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