Otc - Active Ingredient
Active ingredient
Benzalkonium Chloride 0.1%
4 Sure Plus E3 Instant Foam Hand Sanitizer
FDA Label NDC 54410-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Devmar Products Llc for the product 4 Sure Plus E3 Instant Foam Hand Sanitizer (NDC 54410-001). 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, 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 hand sanitizing to decrease bacteria on the 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 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.
Dosage & Administration
Directions
Wash hands with soap and water
Rinse with potable water
Pump a small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands
Rub hands together briskly until dry
Inactive Ingredient
Inactive ingredients
Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid
Package Label.Principal Display Panel
4 SURE Plus E3 Instant Foam Hand Sanitizer
Hand Sanitizer
Alcohol Free
Kills up to 99.9%
of germs on Hands
Refreshing and Soft on Skin
Acceptable for use in food processing facilities
NSF
Nonfood Compounds
Program Listed E3
#147444
550 mL (18.6 fl. oz) Made in the U.S.A.
* Please review the disclaimer below.
