MedPath

Zep FS Antimicrobial Hand Cleaner

66949-105 / 3153 FS Antimicrobial Hand Cleaner

Approved
Approval ID

a5ee28cb-edd6-0a58-e053-2a95a90a8789

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

Zep Inc.

DUNS: 030471374

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 Code66949-105
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEG-6 COCAMIDEInactive
Code: YZ6NLA4O1E
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB
DIDECYLDIMONIUM CHLORIDEInactive
Code: JXN40O9Y9B
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
COCAMIDOPROPYL HYDROXYSULTAINEInactive
Code: 62V75NI93W
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/18/2020

105_3153

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/18/2020

Uses

  • Hand washing to decrease bacteria on skin.
  • For use in food processing facilities.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/18/2020

Directions

  • Wet hands with water.
  • Place hands under dispenser and apply liquid soap.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.
  • Rinse hands thoroughly and dry.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/18/2020

Active ingredient

Benzalkonium chloride 0.13%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/18/2020

Purpose

Antiseptic Hand Wash

WARNINGS SECTION

LOINC: 34071-1Updated: 5/18/2020

Warnings

For external use only.

Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/18/2020

When using this product

  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/18/2020

Stop use and ask a doctor

Stop use and ask a doctor ifskin irritation or redness persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/18/2020

Keep out of reach of children and pets

**Keep out of reach of children and pets.**Children must be supervised in use of this product.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/18/2020

Other information

  • Store at 20 to 25°C (68 to 77°F).
  • Do not freeze.
  • Dispose in accordance with all applicable federal, state and local regulations.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/18/2020

Inactive ingredients

Water, Didecyldimonium Chloride, Cocamidopropyl Hydroxysultaine, Lauramine Oxide, PEG-6 Cocamide, Hydroxyethylcellulose, Methylchloroisothiazolinone and Methylisothiazolinone, Citric Acid

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/18/2020

Questions or comments?

Call 1-877-I-BUY-ZEP (1-877-428-9937)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Zep FS Antimicrobial Hand Cleaner - FDA Drug Approval Details