MedPath

Meijer Antibacterial Spring Rain Hand

Meijer Antibacterial Hand Soap

Approved
Approval ID

35bbdd67-6d15-26b6-e063-6394a90a3f96

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Dec 5, 2024

Manufacturers
FDA

Meijer, Inc.

DUNS: 006959555

Products 3

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 Code79481-0135
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 5, 2024
FDA Product Classification

INGREDIENTS (15)

LAURAMIDOPROPYLAMINE OXIDEInactive
Code: I6KX160QTV
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETRIMONIUM CHLORIDEInactive
Code: UC9PE95IBP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MYRISTAMIDOPROPYLAMINE OXIDEInactive
Code: 3HSF539C9T
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
COCAMIDE MEAInactive
Code: C80684146D
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEInactive
Code: YA22H34H9Q
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
RED 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20V
Classification: IACT

Benzalkonium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79481-0156
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 5, 2024
FDA Product Classification

INGREDIENTS (15)

BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETRIMONIUM CHLORIDEInactive
Code: UC9PE95IBP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LAURAMIDOPROPYLAMINE OXIDEInactive
Code: I6KX160QTV
Classification: IACT
MYRISTAMIDOPROPYLAMINE OXIDEInactive
Code: 3HSF539C9T
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
COCAMIDE MEAInactive
Code: C80684146D
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEInactive
Code: YA22H34H9Q
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
RED 4Inactive
Code: X3W0AM1JLX
Classification: IACT
PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20V
Classification: IACT

Benzalkonium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79481-0125
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 5, 2024
FDA Product Classification

INGREDIENTS (15)

BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETRIMONIUM CHLORIDEInactive
Code: UC9PE95IBP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LAURAMIDOPROPYLAMINE OXIDEInactive
Code: I6KX160QTV
Classification: IACT
MYRISTAMIDOPROPYLAMINE OXIDEInactive
Code: 3HSF539C9T
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
COCAMIDE MEAInactive
Code: C80684146D
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEInactive
Code: YA22H34H9Q
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
RED 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20V
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/5/2025

Meijer Antibacterial Hand Soap

Meijer Antibacterial Hand Soap

Meijer Antibacterial Hand Soaps 7.5floz

11.25 FL OZ

11.25floz

Refill Hand Soap

56floz

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/5/2024

Directions

Wash hands and rinse

WARNINGS SECTION

LOINC: 34071-1Updated: 12/5/2024

Warnings

For external use only

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/5/2024

Activce Ingredient

Active Ingredient Purpose

Benzalkonium Chloride 0.13%......Antibacterial

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/5/2024

Antibacterial

Antibacterial

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/5/2024

Adverse event reporting

QUESTIONS OR COMMENTS? CALL 1-800-370-5360

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/5/2024

Dosage and Administration

Apply 1-2 pumps to hands rub and rinse to reduce the amount of bacteria on hands

Dosage and administration

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/5/2024

Inactive Ingredients

Water, Centimonium Chloride, Glycerin, Lauramidopropylamine Oxide and Myristamidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG 120 Methyl Glucose Dioleate, Citric Acid, Fragrance, Trisodium Ethylenediamine Disuccinate, Methylchloroisothiazolinone, Methylisothiazolinone

Amber: Yellow 5, Red 4

Spring Rain: Red 33, Blue 1

White Tea and Berry: Red 33, Blue 1

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 12/5/2024

Other information: Storage

Avoid extreme temperatures: store at 20-25C (68-77F)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/5/2024

Keep out of reach of children

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

Keep out of reach of children

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Meijer Antibacterial Spring Rain Hand - FDA Drug Approval Details