Guardelle

Manufacturer
Social Medical Supply LLC
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:10

Label at a glance#

ProductGuardelle
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

To decrease bacteria on the skin

Dosage and administration

Liberally apply product to skin by gently massaging until absorbed.  Supervise children in the use of the product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use in eyes.

OTC - DO NOT USE SECTION

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

skin/eye irritation develops.

Directions

DOSAGE & ADMINISTRATION SECTION

Liberally apply product to skin by gently massaging until

absorbed.  Supervise children in the use of the product.

Other Information

SPL UNCLASSIFIED SECTION

• Avoid extreme temperatures.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

FRRONT 1.75FRRONT 1.75

BACK 1.75 sanBACK 1.75 san

7.0 OZ

FRONT 7.0FRONT 7.0

Back 7.0Back 7.0

18 OZ

FRONTT 18FRONTT 18

BACKK 18BACKK 18

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN1
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD1
1020365benzalkonium chloride 0.13 % Topical FoamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85754-000-02Guardelle52 mL in 1 BOTTLE, PUMPAEROSOL, FOAM521
85754-000-07Guardelle207 mL in 1 BOTTLE, PUMPAEROSOL, FOAM2071
85754-000-18Guardelle500 mL in 1 BOTTLE, PUMPAEROSOL, FOAM5001

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85754-00085754-000-02, 85754-000-07, 85754-000-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuardelleBENZALKONIUM CHLORIDESocial Medical Supply LLC8793e3be-7409-4f71-9397-abbeacd27cf82025-12-22WarningsExact identifier
ndc (package): 85754-000-18
ndc (package): 85754-000-07
ndc (package): 85754-000-02
ndc (product): 85754-000
ndc11 (package): 85754000007
ndc11 (package): 85754000002
ndc11 (package): 85754000018
spl id: 3a8774ed-4fdf-48b6-a54b-8db85492cb34
spl set id: 8793e3be-7409-4f71-9397-abbeacd27cf8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.