CHEMSTAR- chloroxylenol solution 
Kay Chemical Co.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antiseptic handwash

Uses

Warnings

For external use only

Do not use

  • in eyes

When using this product

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

Stop use and ask a doctor if

  • skin irritation or redness occurs for more than 72 hours

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

Directions

Other information

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

Questions? call 1.800.529-5458

Principal display panel and representative label

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 label

CHEMSTAR 
chloroxylenol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERIN (UNII: PDC6A3C0OX)  
MONOSODIUM CITRATE (UNII: 68538UP9SE)  
GLYCERYL 1-OLEATE (UNII: D3AEF6S35P)  
SODIUM GLYCOLATE (UNII: B75E535IMI)  
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63146-315-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/23/2021
Labeler - Kay Chemical Co. (003237021)

Revised: 11/2022
Document Id: dbdfd463-816b-49e2-9868-16e2067bc576
Set id: 4a3f3cb0-30ea-4483-a0da-ae5952cdb0f8
Version: 2
Effective Time: 20221114
 
Kay Chemical Co.