FDA.reportPublic FDA data

Antibacterial Foaming Skin Cleanser

Manufacturer
Betco Corporation, Ltd.
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:47:27

Label at a glance#

ProductAntibacterial Foaming Skin Cleanser
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredient

​ ​Benzalkonium Chloride 0.13%

INDICATIONS & USAGE SECTION

Uses

  • ​​Antibacterial skin cleanser.
  • Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

WARNINGS SECTION

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.
  • If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

​Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

OTC - PURPOSE SECTION

Purpose

Antibacterial

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN10
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD10
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY10
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130700427006509GTIN-13: 0700427006509
EAN-13: 0700427006509
GTIN-12: 700427006509
UPC-A: 700427006509
GTIN storage (14 digits): 00700427006509		75104-00_Foaming_Antibacterial_Skin_Cleanser.jpg
BarcodeEAN-130700427015297GTIN-13: 0700427015297
EAN-13: 0700427015297
GTIN-12: 700427015297
UPC-A: 700427015297
GTIN storage (14 digits): 00700427015297		75155-00_Foaming_Antibacterial_Skin_Cleanser.jpg
BarcodeEAN-130700427023551GTIN-13: 0700427023551
EAN-13: 0700427023551
GTIN-12: 700427023551
UPC-A: 700427023551
GTIN storage (14 digits): 00700427023551		75129-00_Foaming_Antibacterial_Skin_Cleanser.jpg
BarcodeEAN-130700427031754GTIN-13: 0700427031754
EAN-13: 0700427031754
GTIN-12: 700427031754
UPC-A: 700427031754
GTIN storage (14 digits): 00700427031754		751H2-00_Foaming_Antibacterial_Skin_Cleanser.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-709-042024-01-30C16284748780-11030e365-213d-111a-e063-dadaa90a10e2Antibacterial Foaming Skin Cleanser
65601-709-292024-01-30C16284748780-11030e365-213d-111a-e063-dadaa90a10e2Antibacterial Foaming Skin Cleanser
65601-709-552024-01-30C16284748780-11030e365-213d-111a-e063-dadaa90a10e2Antibacterial Foaming Skin Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65601-709-04Antibacterial Foaming Skin Cleanser3780 mL in 1 BOTTLE, PLASTICSOAP378010
65601-709-29Antibacterial Foaming Skin Cleanser1000 mL in 1 BAGSOAP100010
65601-709-55Antibacterial Foaming Skin Cleanser208000 mL in 1 DRUMSOAP20800010

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65601-70965601-709-29, 65601-709-55, 65601-709-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 5I753WB2F1MIACT
GERANIOLL837108USYIACT
2-TERT-BUTYLCYCLOHEXYLOXYBUTANOL1DR20642YHIACT
DIHYDROMYRCENOL46L1B02ND9IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALLYL HEPTANOATEAU4CYG9V68IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM NITRATE77CBG3UN78IACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
LINALOOL, (+/-)-D81QY6I88EIACT
2-TERT-BUTYLCYCLOHEXYL ACETATE364FV60913IACT
CITRALT7EU0O9VPPIACT
N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18)9U1Q4T4ZYSIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
LIMONENE, (+)-GFD7C86Q1WIACT

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
Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltd.e5cb1df5-1e13-4a0b-939e-071c577bcf152026-02-26WarningsExact identifier
ndc (package): 65601-709-55
ndc (package): 65601-709-29
ndc (package): 65601-709-04
ndc (product): 65601-709
ndc11 (package): 65601070929
ndc11 (package): 65601070955
ndc11 (package): 65601070904
spl id: 4bbbcd5e-a4e8-d5cc-e063-6294a90a07ae
spl set id: e5cb1df5-1e13-4a0b-939e-071c577bcf15

Reported adverse events (FAERS/openFDA)#

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