Active Ingredient
Benzalkonium chloride 0.13%
Guardelle Aerosol, Foam
FDA Label NDC 85754-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Social Medical Supply Llc for the product Guardelle (NDC 85754-000). 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, uses, warnings, keep out of reach of children., do not use in eyes., stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
To decrease bacteria on the skin
Warnings
For external use only.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use In Eyes.
In case of contact, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor If
skin/eye irritation develops.
Directions
Liberally apply product to skin by gently massaging until
absorbed. Supervise children in the use of the product.
Other Information
• Avoid extreme temperatures.
Inactive Ingredients
Water, Cocamidolpropyl PG-Dimonium Chloride Phospate,
Propylene glycol, Triethylene glycol, Polysorbate-20
Package Label.Principal Display Panel
Guardelle
WATER-BASED FOAMING
HAND SANITIZER
kills 99.9% of common germs &
bacteria in 15 seconds
97% water
Moisturizing, Alcohol-Free
Safe for all hands
All clean with just
1 pump
Manufactured for
WellBefore
2015 Mckenzie Dr. STE 106 Carrollton,
TX, 75006. Made in the USA wellbefore.com
1.7 OZ
7.0 OZ
18 OZ
res
* Please review the disclaimer below.
