FDA.reportPublic FDA data

Fuzion AB Foam

Manufacturer
Zep Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:28:47

Label at a glance#

ProductFuzion AB Foam
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

For washing to decrease bacteria on hands.

Dosage and administration

Wet hands with water. Press pump to dispense product into hands. Massage soap into hands and wrists, emphasizing back of hands, knuckles and cuticles. Rinse hands thoroughly and dry. Store at 20 to 25°C (68 to 77°F). Dispose in accordance with all applicable federal, state and local regulations.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial Hand Wash

Uses

INDICATIONS & USAGE SECTION

For washing to decrease bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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.
  • Press pump to dispense product into hands.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles and cuticles.
  • Rinse hands thoroughly and dry.
  • Store at 20 to 25°C (68 to 77°F).
  • Dispose in accordance with all applicable federal, state and local regulations.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cetrimonium Chloride, Lauryl/Myristyl Amidopropyl Amine Oxide, Glycerin, Di-PPG-2 Myreth-10 Adipate, Tetrasodium Iminodisuccinate, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Glutaral, Citric Acid, Red 4, Yellow 5

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-I-BUY-ZEP (1-800-428-9937)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

111_3388111_3388

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN6
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD6
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY6
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66949-111-16Fuzion AB Foam4800 mL in 1 CASELIQUID48006

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66949-11166949-111-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 4X3W0AM1JLXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLUTARALT3C89M417NIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DI-PPG-2 MYRETH-10 ADIPATE4IN301M0KJIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
WATER059QF0KO0RIACT
LAUROYL/MYRISTOYL AMIDOPROPYL AMINE OXIDEHY9O6ZW9CYIACT
GLYCERINPDC6A3C0OXIACT
TETRASODIUM IMINODISUCCINATEGYS41J2635IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
Fuzion AB FoamBENZALKONIUM CHLORIDEZep Inc.b43ea64e-f7db-2250-e053-2995a90a43b32025-12-26WarningsExact identifier
ndc (package): 66949-111-16
ndc (product): 66949-111
ndc11 (package): 66949011116
spl id: 46de4539-36b3-af75-e063-6294a90acfff
spl set id: b43ea64e-f7db-2250-e053-2995a90a43b3

Reported adverse events (FAERS/openFDA)#

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