FDA.reportPublic FDA data

Primesource

Manufacturer
Midlab Incorporated | Midlab Incoporated
Effective date
2020-05-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:32:01

Label at a glance#

ProductPrimesource
Active ingredientCHLOROXYLENOL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

OTC - ACTIVE INGREDIENT SECTION

OTC ActiveOTC Active

OTC - PURPOSE SECTION

PurposePurpose

INDICATIONS & USAGE SECTION

IndicationsIndications

WARNINGS SECTION

WarningsWarnings

OTC - ASK DOCTOR SECTION

Ask DoctorAsk Doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KOOROCKOOROC

DOSAGE & ADMINISTRATION SECTION

DosageDosage

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
70542-70670542-706-41

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

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
c55fb03a-9181-3cfe-e053-2a95a90a1ef276661b63-be7c-2c1b-e053-2a91aa0ad93f2021-06-22WarningsExact identifier
spl set id: 76661b63-be7c-2c1b-e053-2a91aa0ad93f

Reported adverse events (FAERS/openFDA)#

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