FDA.reportPublic FDA data

ASSURED

Manufacturer
HIGIENE + SALUD, S.A. DE C.V.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:46:41

Label at a glance#

ProductASSURED
Active ingredientBENZALKONIUM CHLORIDE
Label structure14 sections

Storage and handling

Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.125%

OTC - PURPOSE SECTION

Antibacterial

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Over large areas of the body if you are allergic to any of the ingredients.

OTC - WHEN USING SECTION

Do not get into eyes.

If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

If irritation or rash develops and continues for more than 72 hours.

OTC - ASK DOCTOR SECTION

If irritation or rash develops and continues for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

· Thoroughly wipe hands and face as desired.

· allow to dry without wiping.

· Discard wipe in trash receptacle after use. Do not flush.

STORAGE AND HANDLING SECTION

Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Fragrance, Methylchloroisothiazolinone/ Methylisothiazolinone, Aloe Extract, Tetrasodium EDTA, Citric Acid, Vitamin E.

DOSAGE & ADMINISTRATION SECTION

Dosage: Swab - Administration: Topical

SUMMARY OF SAFETY AND EFFECTIVENESS

  • Convenient

Easy to use & carry anywhere!

  • Clean-up

Use to wash up quickly when soap and water are not available.

  • Moisturize

Contains soothing Aloe to help moisturize your skin and leave it feeling soft and smooth.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front PanelFront Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2276303benzalkonium Cl 0.125 % Medicated PadPSN4
2276303benzalkonium chloride 1.25 MG/ML Medicated PadSCD4
2276303benzalkonium chloride 0.125 % Medicated WipeSY4
2276303benzalkonium chloride 0.125 % Topical ClothSY4
2276303benzalkonium chloride 0.125 % Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52629-800-032023-07-28C16284748780-10191ceaa-61c6-198a-e063-dbdaa90aec3e830ff4e1-53fd-8d97-e053-2991aa0aa68f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52629-800-03ASSURED16 in 1 BOXSWAB164
52629-800-03ASSURED1 in 1 PACKAGESWAB14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52629-800ASSURED (BENZALKONIUM CHLORIDE) SWAB [HIGIENE + SALUD, S.A. DE C.V.]4Legacy NDC, 2 package rows20220114_830ff4e1-53fd-8d97-e053-2991aa0aa68f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52629-80052629-800-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
d57c1f46-847a-402d-e053-2995a90a7d67830ff4e1-53fd-8d97-e053-2991aa0aa68f2022-01-13WarningsExact identifier
spl id: d57c1f46-847a-402d-e053-2995a90a7d67
spl set id: 830ff4e1-53fd-8d97-e053-2991aa0aa68f

Reported adverse events (FAERS/openFDA)#

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