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Antibacterial Skin Cleanser

Dosage form: soap
Ingredients: CHLOROXYLENOL 3.75mg in 1mL
Labeler: Betco Corporation, Ltd.
NDC Code: 65601-708

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.

Antibacterial Skin Cleanser

​Active Ingredient

Chloroxylenol 0.375%

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.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.

Inactive Ingredients

​Water, Sodium Laureth lSulfate, Cocamidopropyl betadine, Phenoxyethanol, Coco MIPA, Glycol Stearate, DMDM Hydantoin, Propylene Glycol, Sodium Chloride, Fragrance, Glycerin, Ethanol,  D&C Green #5, FD&C Yellow #5.

Purpose

Antibacterial

Winning Hands Antibacterial

KEEP OUT OF REACH OF CHILDREN

ANTIBACTERIAL SKIN CLEANSER 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-708
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL3.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
PHENOXYETHANOL 
COCO MONOISOPROPANOLAMIDE 
DMDM HYDANTOIN 
GLYCOL STEARATE 
PROPYLENE GLYCOL 
SODIUM CHLORIDE 
GLYCERIN 
ALCOHOL 
D&C GREEN NO. 5 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:65601-708-043780 mL in 1 JUG
2NDC:65601-708-19900 mL in 1 BAG
3NDC:65601-708-412000 mL in 1 BAG
4NDC:65601-708-55207900 mL in 1 DRUM
5NDC:65601-708-101100 mL in 1 BAG
6NDC:65601-708-291000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/12/2012
Labeler - Betco Corporation, Ltd. (070307547)
Registrant - Betco corporation, Ltd. (070307547)
Establishment
NameAddressID/FEIOperations
Betco Corporation, Ltd.070307547manufacture(65601-708), pack(65601-708), label(65601-708)

Revised: 11/2016
 
Betco Corporation, Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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