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Antibacterial Foaming Hand Wash

CVP 628.002/628AF Antibacterial Foaming Hand Wash

Approved
Approval ID

b56aefb5-7134-44dd-b341-b9a3515db35e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Salado Sales Inc

DUNS: 009830555

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 Code57243-628
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (13)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
LAURAMIDOPROPYLAMINE OXIDEInactive
Code: I6KX160QTV
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
MYRISTAMIDOPROPYLAMINE OXIDEInactive
Code: 3HSF539C9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SULISOBENZONEInactive
Code: 1W6L629B4K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 1.3 mg in 1 mL
Code: F5UM2KM3W7
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal display panel

CVP ®

HEALTH

ANTIBACTERIAL

FOAMING HAND WASH

7.5 FL OZ (221 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Use

for handwashing to decrease bacteria on the skin

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/1/2025

Adverse reactions

Distributed by:

Consumer Value Products, Inc.

Temple TX 76503

CVPProducts.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient

Benzalkonium chloride 0.13%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Antibacterial

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

For external use only: hands only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/1/2025

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes with water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Directions

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

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Antibacterial Foaming Hand Wash - FDA Drug Approval Details