FDA.reportPublic FDA data

Smart Defender

Manufacturer
Midlab, Inc | Midlab, Inc.
Effective date
2024-08-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:56:10

Label at a glance#

ProductSmart Defender
Active ingredientCHLOROXYLENOL
Label structure1 sections

Label contents#

Full prescribing information#

Principal label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Active

OTC - ACTIVE INGREDIENT SECTION

ActiveActive

OTC Purpose

OTC - PURPOSE SECTION

PurposePurpose

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and UsesIndications and Uses

Warnings

WARNINGS SECTION

WarningsWarnings

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask DoctorAsk Doctor

KOOROC

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KOOROCKOOROC

Dosage and Admin

DOSAGE & ADMINISTRATION SECTION

Dosage and adminDosage and admin

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientInactive ingredient

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
70542-70770542-707-41

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
SODIUM LAURETH SULFATEBPV390UAP0IACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM SULFATE0YPR65R21JIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
CHLOROXYLENOL0F32U78V2QACTIB
FD&C YELLOW NO. 5I753WB2F1MIACT
BORIC ACIDR57ZHV85D4IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT

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
204cb02e-a84d-d3f4-e063-6394a90ab4b989925257-9be8-4265-e053-2a95a90a25552024-08-22WarningsExact identifier
spl id: 204cb02e-a84d-d3f4-e063-6394a90ab4b9
spl set id: 89925257-9be8-4265-e053-2a95a90a2555

Reported adverse events (FAERS/openFDA)#

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