FDA.reportPublic FDA data

Dermatize

Manufacturer
Anderson Chemical Company
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:46

Label at a glance#

ProductDermatize
Active ingredientBENZETHONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Hands need not be washed prior to using. For one step hand wash/antiseptic skin cleaning. Place 5 milliliters in palm of hand, add water, work up a lather and scrub for 30 seconds. Rinse hands thoroughly with potable water after washing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzethonium chloride, 0.2% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on skin.

Warning

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • discontinue use if irritatio and redness develop.
  • do not use in or near eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if conditions persist 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, except under adult supervision.

  • In case of accidental ingestion, see medical attention or contact a poision control cernter immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Hands need not be washed prior to using.
  • For one step hand wash/antiseptic skin cleaning.
  • Place 5 milliliters in palm of hand, add water, work up a lather and scrub for 30 seconds.
  • Rinse hands thoroughly with potable water after washing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid; 1,3-Dihydroxymethyl-5,5-dimethylhydantoin and 3-iodo-2-propynyl butyl carbamate; Ethoxylated C11 Alcohol; Hydrogenated starch hydrolysate; Hydroxypropyl methylcellulose; N-alkykl (C12-C16)-N, N-dimethylamine oxide; Sodium hydroxide; Water.

Questions or comments?

OTC - QUESTIONS SECTION

320-693-2477

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049111benzethonium chloride 0.2 % Topical SolutionPSN1
1049111benzethonium chloride 2 MG/ML Topical SolutionSCD1
1049111benzethonium chloride 0.2 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63131-0004-12022-01-28C16284748780-1d6a99b39-56eb-a426-e053-dadaa90af4c2a501d01d-a3ff-10aa-e053-2a95a90aa7e0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63131-0004-1Dermatize15140 in 1 CASELIQUID151401
63131-0004-1Dermatize3785 mL in 1 JUGLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63131-0004DERMATIZE (BENZETHONIUM CHLORIDE) LIQUID [ANDERSON CHEMICAL COMPANY]1Legacy NDC, 2 package rows20201002_a501d01d-a3ff-10aa-e053-2a95a90aa7e0.zip

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
63131-000463131-0004-1

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
HYDROXYMETHYL CELLULOSE273FM27VK1IACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
COCAMINE OXIDEQWA2IZI6FIIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
UNDECETH-7R6B5PCO2JNIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
DMDM HYDANTOINBYR0546TOWIACT

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
a501d01d-a400-10aa-e053-2a95a90aa7e0a501d01d-a3ff-10aa-e053-2a95a90aa7e02020-05-06WarningsExact identifier
spl id: a501d01d-a400-10aa-e053-2a95a90aa7e0
spl set id: a501d01d-a3ff-10aa-e053-2a95a90aa7e0

Reported adverse events (FAERS/openFDA)#

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