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Ultra Mild Antibacterial Skin Cleanser

Medically reviewed on March 1, 2018

Dosage form: soap
Ingredients: TRICLOSAN 3.0mg in 1mL
Labeler: Betco Corporation, Ltd.
NDC Code: 65601-705

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.

Ultra Mild Antibacterial Skin Cleanser

​Active Ingredient

​Triclosan 0.30%

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 Lauryl lSulfate, Cocamidopropyl betadine, Propylene Glycol, Sodium Chloride, Isopropryl Alcoho, Cocamide MEA, Dimethicone PEG-7 Cocoate, DMDM Hydantoin, Fragrance, Glycerine, Tocopheryl Acetate, 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

ULTRA MILD ANTIBACTERIAL SKIN CLEANSER 
tricolsan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-705
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN3.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
PROPYLENE GLYCOL 
SODIUM CHLORIDE 
ISOPROPYL ALCOHOL 
PEG-4 RAPESEEDAMIDE 
DIMETHICONE 
GLYCERIN 
TOCOPHEROL 
DIISOPROPANOLAMINE 
MAGNESIUM SULFATE 
FD&C YELLOW NO. 5 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:65601-705-101100 mL in 1 BAG
2NDC:65601-705-043780 mL in 1 BOTTLE, PLASTIC
3NDC:65601-705-412000 mL in 1 BAG
4NDC:65601-705-19900 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2016
Labeler - Betco Corporation, Ltd. (070307547)
Registrant - Betco corporation, Ltd. (070307547)
Establishment
NameAddressID/FEIOperations
Betco Corporation, Ltd.070307547manufacture(65601-705), label(65601-705), pack(65601-705)

 
Betco Corporation, Ltd.

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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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