FDA.reportPublic FDA data

CHEMSTAR

Manufacturer
Kay Chemical Co.
Effective date
2024-08-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:56:07

Label at a glance#

ProductCHEMSTAR
Active ingredientCHLOROXYLENOL
Label structure9 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

wet hands and forearms dispense a palmful to hands and forearms scrub thoroughly  Rinse and dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol, 0.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in eyes

When using this product

OTC - WHEN USING SECTION

  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • skin irritation or redness occurs for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands and forearms
  • dispense a palmful to hands and forearms
  • scrub thoroughly 
  • Rinse and dry

Other information

REFERENCES SECTION

  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713

INACTIVE INGREDIENT SECTION

Inactive ingredientsWater (Aqua), Potassium Cocoate, Hexylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Sodium lauryl sulfate, Glycerin, Sodium Citrate, Glyceryl Oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, Lauryl Glucoside, Magnesium Nitrate, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Yellow 5, Methylisothiazolinone, Red 4

OTC - QUESTIONS SECTION

Questions? call 1.800.529-5458

Principal display panel and representative label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHEMSTAR 

Foaming Antibacterial 

Hand Soap

KEEP OUT OF REACH OF CHILDREN

Chloroxylenol 0.5%

Net Contents 42 US fl ox (1250 mL)

111280

Distributed by: Kay Chemical Company

8300 Capital Drive - Greensboro, NC 27409

Made in USA

CSUSA 779394/8000/0621

representative labelrepresentative label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-315CHEMSTAR (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]3Legacy NDC20240823_4a3f3cb0-30ea-4483-a0da-ae5952cdb0f8.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63146-31563146-315-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QACTIB
WATER059QF0KO0RIACT
POTASSIUM COCOATEF8U72V8ZXPIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SODIUM SULFATE0YPR65R21JIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERYL OLEATE4PC054V79PIACT
SODIUM GLYCOLATEB75E535IMIIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
MAGNESIUM NITRATE77CBG3UN78IACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 4X3W0AM1JLXIACT

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
97bbe995-b1ba-4de1-a9dc-66d577ecf60e4a3f3cb0-30ea-4483-a0da-ae5952cdb0f82025-12-31WarningsExact identifier
spl set id: 4a3f3cb0-30ea-4483-a0da-ae5952cdb0f8

Reported adverse events (FAERS/openFDA)#

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