Otc - Active Ingredient
Benzalkonium Chloride
Handsoap
FDA Label NDC 36800-535
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Handsoap (NDC 36800-535). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, dosage section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Handwashing
Warnings
For External Use only
Otc - When Using
Avoid contact with eyes. In case of contact, flush with water
Otc - Stop Use
Stop using this product and ask a doctor if irritation or redness develops and lasts.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, get medical help or contact a Poison Control Center immediately
Indications & Usage
Directions
. Use only to refill a Liquid Hand Soap pump bottle.
. From pump bottle, apply onto wet hands.
. Lather and rinse thoroughly.
Dosage Section
Topical use only. Use when required.
Storage And Handling
Store at room temperature
Inactive Ingredient
Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).
Package Label.Principal Display Panel
56 Oz (06 25414 15)
* Please review the disclaimer below.
