FDA.reportPublic FDA data

Zep FS Antimicrobial Hand Cleaner

Manufacturer
Zep Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:28:45

Label at a glance#

ProductZep FS Antimicrobial Hand Cleaner
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic Hand Wash

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

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

When using this product

OTC - WHEN USING SECTION

  • 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.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

OTHER SAFETY 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 ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

105_3153105_3153

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN9
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD9
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY9
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66949-105-01Zep FS Antimicrobial Hand Cleaner11400 mL in 1 CASELIQUID114009
66949-105-04Zep FS Antimicrobial Hand Cleaner3785 mL in 1 CASELIQUID37859
66949-105-11Zep FS Antimicrobial Hand Cleaner6000 mL in 1 CASELIQUID60009
66949-105-24Zep FS Antimicrobial Hand Cleaner15140 mL in 1 CASELIQUID151409
66949-105-85Zep FS Antimicrobial Hand Cleaner208198 mL in 1 DRUMLIQUID2081989

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66949-10566949-105-01, 66949-105-11, 66949-105-24, 66949-105-85, 66949-105-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)S38J6RZN16IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
Zep FS Antimicrobial Hand CleanerBENZALKONIUM CHLORIDEZep Inc.a5ee28cb-edd6-0a58-e053-2a95a90a87892025-12-26WarningsExact identifier
ndc (package): 66949-105-01
ndc (package): 66949-105-11
ndc (package): 66949-105-85
ndc (package): 66949-105-24
ndc (package): 66949-105-04
ndc (product): 66949-105
ndc11 (package): 66949010504
ndc11 (package): 66949010511
ndc11 (package): 66949010524
ndc11 (package): 66949010501
ndc11 (package): 66949010585
spl id: 46de3c7a-b5f5-a0c8-e063-6394a90ab0c2
spl set id: a5ee28cb-edd6-0a58-e053-2a95a90a8789

Reported adverse events (FAERS/openFDA)#

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