MedPath

Walgreen

Walgreens Handsoap-0363-0242

Approved
Approval ID

c992cf19-786c-d794-e053-2995a90af067

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Walgreen Co

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BENZALKONIUM CHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0242
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
BENZALKONIUM CHLORIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (17)

PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20V
Classification: IACT
FRAGRANCE CLEAN ORC0600327Inactive
Code: 329LCV5BTF
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 130 mg in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LAURAMIDOPROPYLAMINE OXIDEInactive
Code: I6KX160QTV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CETRIMONIUM CHLORIDEInactive
Code: UC9PE95IBP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
COCO MONOETHANOLAMIDEInactive
Code: C80684146D
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal Display Panel

Principal Display Panel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/6/2021

Uses

helps eliminate bacteria on hands.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/6/2021

Directions

  • use to refill soap pump bottle
  • from pump bottle, apply onto wet hands
  • Lather and rinse thoroughly.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/6/2021

Other Information

Store at room temperature

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/6/2021

Active Ingredient.

Benzalkonium Chloride (0.13%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/6/2021

Purpose

Antibacterial

WARNINGS SECTION

LOINC: 34071-1Updated: 8/6/2021

Warnings

For external use only

When using this product

Avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and lasts

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/6/2021

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/6/2021

Questions or comments?

1-800-925-4733

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