FDA.reportPublic FDA data

SOFTCIDE

Manufacturer
Erie Scientific LLC | KUTOL PRODUCTS COMPANY
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:26:53

Label at a glance#

ProductSOFTCIDE
Active ingredientCHLOROXYLENOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

CHLOROXYLENOL............1%

OTC - PURPOSE SECTION

ANTICEPTIVE AGENT

INDICATIONS & USAGE SECTION

Handwash to help reduce bacteria that can potentially cause disease. Reduces the risk and chance of cross -infection.

WARNINGS SECTION

For external use only.

If swallowed seek medical help or contact poison control immediately

Avoid contact with eyes. If contact occurs flush with water

Discontinue use and contact a health practitioner if irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION SECTION

Wet skin and apply a sufficient amount on hands and forearms

Scrub well and rinse thoroughly after washing

INACTIVE INGREDIENT SECTION

OLIVE OIL
WALNUT OIL
JOJOBA OIL
RICE BRAN OIL
GAMOLENIC ACID
ALKYL (C12-15) BENZOATE
QUATERNIUM-15
EDETATE SODIUM
CITRIC ACID MONOHYDRATE
ALOE VERA LEAF
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)
ALLANTOIN
COCAMIDOPROPYL BETAINE
SODIUM LAURETH SULFATE
COCAMIDOPROPYL HYDROXYSULTAINE
POLYSORBATE 20
PEG-150 DISTEARATE
SODIUM LAUROYL SARCOSINATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55863-155-512022-01-31C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F
55863-155-622022-01-31C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F
55863-155-652022-01-31C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F
55863-155-702022-01-31C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F
55863-155-512022-01-28C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F
55863-155-622022-01-28C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F
55863-155-652022-01-28C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F
55863-155-702022-01-28C16284748780-1d6a99b39-52c3-a426-e053-dadaa90af4c2Erie Scientific F155F

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55863-15555863-155-51, 55863-155-62, 55863-155-65, 55863-155-70

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-150 DISTEARATE6F36Q0I0ACIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
WALNUT OILY0P3555R51IACT
OLIVE OIL6UYK2W1W1EIACT
JOJOBA OIL724GKU717MIACT
RICE BRAN OILLZO6K1506AIACT
GAMOLENIC ACID78YC2MAX4OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
QUATERNIUM-15E40U03LEM0IACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
ALLANTOIN344S277G0ZIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
POLYSORBATE 207T1F30V5YHIACT
CHLOROXYLENOL0F32U78V2QACTIB
OMEGA-3 FATTY ACIDS71M78END5SIACT

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
03a8c5b9-b081-8b10-e063-6294a90ac5784e2726f7-f199-1c0d-e054-00144ff8d46c2023-08-24WarningsExact identifier
spl id: 03a8c5b9-b081-8b10-e063-6294a90ac578
spl set id: 4e2726f7-f199-1c0d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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