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Premium Antibacterial Skin Cleanser

Dosage form: soap
Ingredients: CHLOROXYLENOL 5.0mg in 1mL
Labeler: Betco Corporation, Ltd.
NDC Code: 65601-706

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.

Premium Antibacterial Skin Cleanser

​Active Ingredient

​Chloroxylenol 0.5%

Uses

  • ​Antibacterial hand cleaner.
  • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • Children under the age of 6 should be supervised by an adult when using this product.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 1-2 pumps of product onto wet palm.
  • Lather and rinse hands with clean water

Inactive Ingredients

​Water, Sodium Laureth Suulfate, Sodium Lauryl Sulfate, Coco MIPA, Ethanol, Phenoxyethanol, Cocamidopropyl Betaine, sodium chloride, Tetrasodium EDTA, Fragrance Glycerine, Allantoin,  Aloe Barbadensis Leaf Juice, Sodium Hydroxyacetate, Magnesium Saluts, Methylchloroisothiazinone, Sodium Hydroxide, Trisodium Nitrilotriacetate, Methylisothiazolinone,  FD&C Yellow #5, FD&C Red #40.

Questions or Comments?Phone: (800) 777-9343

MDS information:​(800) 891-4965

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

PREMIUM ANTIBACTERIAL SKIN CLEANSER 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-706
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL5.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
SODIUM LAURYL SULFATE 
COCO DIETHANOLAMIDE 
ALCOHOL 
PHENOXYETHANOL 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
EDETATE SODIUM 
GLYCERIN 
ALLANTOIN 
ALOE VERA LEAF 
SODIUM GLYCOLATE 
MAGNESIUM SULFATE 
METHYLCHLOROISOTHIAZOLINONE 
SODIUM HYDROXIDE 
TRISODIUM NITRILOTRIACETATE 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:65601-706-19900 mL in 1 BAG
2NDC:65601-706-101100 mL in 1 BAG
3NDC:65601-706-043780 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2016
Labeler - Betco Corporation, Ltd. (070307547)
Registrant - Betco corporation, Ltd. (070307547)
Establishment
NameAddressID/FEIOperations
Betco Corporation, Ltd.070307547manufacture(65601-706), label(65601-706), pack(65601-706)

 
Betco Corporation, Ltd.

Medically reviewed on Jun 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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