GUARDELLE- benzalkonium chloride aerosol, foam

Guardelle by

Drug Labeling and Warnings

Guardelle by is a Otc medication manufactured, distributed, or labeled by Social Medical Supply LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium chloride 0.13%

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

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

INGREDIENTS AND APPEARANCE

GUARDELLE 
benzalkonium chloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85754-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85754-000-02	52 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/16/2025
2	NDC: 85754-000-07	207 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/16/2025
3	NDC: 85754-000-18	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	10/16/2025

Labeler - Social Medical Supply LLC (118056777)