FDA.reportPublic FDA data

SMART AND CLEAN

Manufacturer
INDELPA, S.A DE C.V
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:04

Label at a glance#

ProductSMART AND CLEAN
Active ingredientBENZALKONIUM CHLORIDE
Label structure14 sections

Storage and handling

Store at room temperature. Cold weather may cloud this product. Its antisceptic properties are not affected.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.130%

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on
the skin. May be used on face, arms and
legs.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients

OTC - WHEN USING SECTION

this product 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 hellp or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE 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. Its antisceptic
properties are not affected.

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

Dosage: Liquid

Administration: Topical

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMART AND CLEANSMART AND CLEAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70697-806-012025-01-30C16284748780-12cef2736-6211-d83d-e063-dadaa90ab31fba8849e0-13d6-9efb-e053-2995a90ac0fe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70697-806-01SMART AND CLEAN24 in 1 CASECLOTH242
70697-806-01SMART AND CLEAN0.13 g in 1 POUCHCLOTH0.132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70697-806SMART AND CLEAN (BENZALKONIUM CHORIDE) CLOTH [INDELPA, S.A DE C.V]2Legacy NDC, 2 package rows20230111_ba8849e0-13d6-9efb-e053-2995a90ac0fe.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70697-80670697-806-01

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
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT

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
f1f1b263-dca3-60e7-e053-2995a90ae493ba8849e0-13d6-9efb-e053-2995a90ac0fe2023-01-10WarningsExact identifier
spl id: f1f1b263-dca3-60e7-e053-2995a90ae493
spl set id: ba8849e0-13d6-9efb-e053-2995a90ac0fe

Reported adverse events (FAERS/openFDA)#

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