FDA.reportPublic FDA data

DermaFoam Premium Antibacterial

Manufacturer
Superior Chemical | Betco Corporation, Ltd.
Effective date
2020-07-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:23:05

Label at a glance#

ProductDermaFoam Premium Antibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DermaFoam Premium Antibacterial Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredient

​ ​Benzalkonium Chloride 0.13%

DermaFoam Premium Antibacterial Indications

INDICATIONS & USAGE SECTION

Uses

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

DermaFoam Premium Antibacterial Warnings

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.

DermaFoam Premium Antibacterial Dosage

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.

DermaFoam Premium Antibacterial Inactive Ingredients

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.

DermaFoam Premium Antibacterial Purpose

OTC - PURPOSE SECTION

Purpose

Antibacterial

DermaFoam Premium Antibacterial Keep our of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

DermaFoam Premium Antibacterial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75129 Derma Foam75129 Derma Foam

75129-00_Derma Foam Premium Antibacterial.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53125-709-292025-01-30C16284748780-11030e364-fcef-111a-e063-dadaa90a10e2DermaFoam Premium Antibacterial
53125-709-292024-10-01C16284748780-11030e364-fcef-111a-e063-dadaa90a10e2DermaFoam Premium Antibacterial
53125-709-292024-07-30C16284748780-11030e364-fcef-111a-e063-dadaa90a10e2DermaFoam Premium Antibacterial
53125-709-292024-01-30C16284748780-11030e364-fcef-111a-e063-dadaa90a10e2DermaFoam Premium Antibacterial

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53125-709DERMAFOAM PREMIUM ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOAP [SUPERIOR CHEMICAL]3Legacy NDC20200730_861a0cc3-90b6-0ffc-e053-2991aa0a7501.zip

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
53125-70953125-709-29

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

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
41989b98-14e9-39b3-e063-6294a90a7d8d861a0cc3-90b6-0ffc-e053-2991aa0a75012025-10-20WarningsExact identifier
spl set id: 861a0cc3-90b6-0ffc-e053-2991aa0a7501

Reported adverse events (FAERS/openFDA)#

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