FDA.reportPublic FDA data

AFCO 5508 Sanifect Foam-E II

Manufacturer
Zep Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:28:38

Label at a glance#

ProductAFCO 5508 Sanifect Foam-E II
Active ingredientCHLOROXYLENOL
Label structure12 sections

Indications and uses

Hand wash to help reduce bacteria on skin that potentially can cause diseases. Helps prevent cross contamination by hand contact. Recommended for repeat use.

Dosage and administration

For one step hand washing and sanitizing, wet hands with water. Apply a generous amount of product in palm of hand and work into later. Rinse thoroughly with potable water. Dry hands completely.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 1.0% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand wash to help reduce bacteria on skin that potentially can cause diseases.
  • Helps prevent cross contamination by hand contact.
  • Recommended for repeat use.

Warnings

WARNINGS SECTION

For external use only – Harmful if swallowed.

When using this product

OTC - WHEN USING SECTION

When using this product do not use in or near eyes. If eye contact occurs, rinse eyes thoroughly with water. Discontinue use if irritation or redness develops.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For one step hand washing and sanitizing, wet hands with water.
  • Apply a generous amount of product in palm of hand and work into later.
  • Rinse thoroughly with potable water.
  • Dry hands completely.

Other information

OTHER SAFETY INFORMATION

For Food Processing, Food Service and Professional Use Only.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Ethyl Alcohol, Propylene Glycol, Cocamide MEA, Glycerin, Disodium EDTA.

Questions or comments?

OTC - QUESTIONS SECTION

For product or technical information, contact ZEP, INC. Monday to Friday 8 AM to 4 PM EST at 1-877-428-9937 or visit our website at www.zep.com.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

139 AF5508139 AF5508

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413257chloroxylenol 1 % Medicated Liquid SoapPSN2
413257chloroxylenol 10 MG/ML Medicated Liquid SoapSCD2
413257chloroxylenol 1 % Medicated Liquid SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66949-139-01AFCO 5508 Sanifect Foam-E II208198 mL in 1 DRUMLIQUID2081982
66949-139-02AFCO 5508 Sanifect Foam-E II6000 mL in 1 CASELIQUID60002
66949-139-03AFCO 5508 Sanifect Foam-E II3785 mL in 1 CASELIQUID37852

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66949-13966949-139-01, 66949-139-02, 66949-139-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
WATER059QF0KO0RIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
CHLOROXYLENOL0F32U78V2QACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
ALCOHOL3K9958V90MIACT
COCAMIDE MEAC80684146DIACT

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
AFCO 5508 Sanifect Foam-E IIETHANOLZep Inc.347995ef-38bd-7cdb-e063-6394a90adec32025-12-26WarningsExact identifier
ndc (package): 66949-139-03
ndc (package): 66949-139-01
ndc (package): 66949-139-02
ndc (product): 66949-139
ndc11 (package): 66949013901
ndc11 (package): 66949013903
ndc11 (package): 66949013902
spl id: 46dfe3ae-bb1d-7a50-e063-6394a90a96c7
spl set id: 347995ef-38bd-7cdb-e063-6394a90adec3

Reported adverse events (FAERS/openFDA)#

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