Active Ingredient
Chloroxylenol 0.75% w/w
Summit 368 Foaming Antimicrobial Hand Solution
FDA Label NDC 23590-225
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 368 Foaming Antimicrobial Hand (NDC 23590-225). 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
Skin Antimicrobial
Use
reduces amount of bacteria on hands
Warnings
For external use only. Do not use in eyes.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician.
For institutional and professional use only.
Otc - Keep Out Of Reach Of Children
Not for use on children under six months of age.
Directions
Wet hands and forearms.
Apply a palmful to hands and forearms.
Scrub thoroughly for at least fifteen seconds.
Rinse completely and dry.
Inactive Ingredients
Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1
Package Label.Principal Display Panel
Product Label (850 mL Cartridge (Front))
Product Label (850 mL Cartridge (Back))
* Please review the disclaimer below.
