FDA.reportPublic FDA data

Assure

Manufacturer
Anderson Chemical Company
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:52

Label at a glance#

ProductAssure
Active ingredientBENZETHONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Hands need not be washed prior to using. For one step handwash/antibacterial skin cleaning. Place product in palm of hand, add water, work up a lather. 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

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacterial on skin.
  • Recommended for repeated use.

Warning

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Hands need not be washed prior to using.
  • For one step handwash/antibacterial skin cleaning.
  • Place product in palm of hand, add water, work up a lather.
  • Rinse hands thoroughly with potable water after washing.

Inactive ingredients

INACTIVE INGREDIENT SECTION


C9-11 Pareth-6; Caprylyl/Capryl Oligpglucoside; Citric acid; DMDM Hydantoin; Dye; Fragrance; Glycerine; Poly(Laurylglucoside)-7; Water.

Questions or comments?

OTC - QUESTIONS SECTION

320-693-2477

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Assure labelAssure label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243889benzethonium chloride 0.2 % Medicated Liquid SoapPSN1
1243889benzethonium chloride 2 MG/ML Medicated Liquid SoapSCD1
1243889benzethonium chloride 0.2 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63131-1132-12022-01-28C16284748780-1d6a99b39-e650-a426-e053-dadaa90af4c2a61ac2f6-f77f-6adf-e053-2995a90ad434

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63131-1132-1Assure3785 mL in 1 JUGLIQUID37851
63131-1132-1Assure7570 in 1 CASELIQUID75701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63131-1132ASSURE (BENZETHONIUM CHLORIDE) LIQUID [ANDERSON CHEMICAL COMPANY]1Legacy NDC, 2 package rows20201119_a61ac2f6-f77f-6adf-e053-2995a90ad434.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63131-113263131-1132-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DMDM HYDANTOINBYR0546TOWIACT
C9-11 PARETH-6KCE0V8JT7WIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
GLYCERINPDC6A3C0OXIACT
POLY(LAURYLGLUCOSIDE)-7VB00RDE21RIACT
WATER059QF0KO0RIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZYL ALCOHOLLKG8494WBHIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
a61ac2f6-f780-6adf-e053-2995a90ad434a61ac2f6-f77f-6adf-e053-2995a90ad4342020-05-20WarningsExact identifier
spl id: a61ac2f6-f780-6adf-e053-2995a90ad434
spl set id: a61ac2f6-f77f-6adf-e053-2995a90ad434

Reported adverse events (FAERS/openFDA)#

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