Otc - Active Ingredient
Active ingredient
Benzalkonium Chloride 0.13%
Antibacterial Hand Mousse
FDA Label NDC 76268-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Organica (uk) Ltd for the product Antibacterial Hand Mousse (NDC 76268-002). 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 - stop use, otc - keep out of reach of children, 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
Antimicrobial
Indications & Usage
Uses
For handwashing to decrease bacteria on skin.
Recommended for repeated use.
Warnings
Warnings
For external use only.
Otc - When Using
When using this product avoid contact with eyes.
In case of eye contact, flush eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops, or if conditions 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.
Dosage & Administration
Directions
Pump a small amount of foam into the palm of hand
Rub thoroughly over all surfaces of both hands for 15 seconds
Rinse with potable water.
Inactive Ingredient
Inactive ingredients
Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide.
Package Label.Principal Display Panel
ANTIBACTERIAL
HAND SOAP
MOUSSE
CLEANS IN SECONDS
KILLS 99.9% of BACTERIA
FREE from ALCOHOL
CHLORINE, FRAGRANCE and DYES
8.45fl oz
(250ml)
* Please review the disclaimer below.
