FDA.reportPublic FDA data

Assured

Manufacturer
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
Effective date
2016-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:00

Label at a glance#

ProductAssured
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.115%

OTC - PURPOSE SECTION

Purpose

Antibacterial

INDICATIONS & USAGE SECTION

Use   decreases bacteria on skin

WARNINGS SECTION

Warnings

For external use only

Do not use

-over large areas of the body if you are allergic to any of the ingredients

When using this product avoid contact with eyes and face.

If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and

continues for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

-for adults and children of 2 years and over use

on hands and face to clean and refresh, allow skin to air dry.

-For children under 2 years ask a doctor before using

INACTIVE INGREDIENT SECTION

Inactive ingredient

Water, propylene glycol, glycerin, cocamidopropyl

betaine, polyaminopropyl biguanide, aloe barbadensis leaf extract,

tocopheryl acetate, peg-54 hydrigenated castor oil, disodium edta,

citric acid, fragrance, methylchloroisothiazolinone,

methylsothiazolinone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70031-002-022020-01-31C16284748780-19d75b9d1-2799-f424-e053-dadaa90a57cebcd59ea1-b11e-4e40-b7e9-372f90bf3dc4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70031-002-01Assured.1 g in 1 PACKETLOTION.11
70031-002-02Assured20 in 1 BAGLOTION201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70031-002ASSURED (BENZALKONIUM CHLORIDE) LOTION [TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY]1Legacy NDC, 2 package rows20160901_bcd59ea1-b11e-4e40-b7e9-372f90bf3dc4.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70031-00270031-002-01, 70031-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYAMINOPROPYL BIGUANIDE322U039GMFIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-54 HYDROGENATED CASTOR OIL0WZF1506N9IACT
EDETATE DISODIUM7FLD91C86KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYL SOYATE808DL597QPIACT

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
827a39c0-4324-4725-8787-b29cee24a575bcd59ea1-b11e-4e40-b7e9-372f90bf3dc42016-08-31WarningsExact identifier
spl id: 827a39c0-4324-4725-8787-b29cee24a575
spl set id: bcd59ea1-b11e-4e40-b7e9-372f90bf3dc4

Reported adverse events (FAERS/openFDA)#

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