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Antibacterial by Seatex Ltd

Dosage form: soap
Ingredients: CHLOROXYLENOL 40g in 1kg
Labeler: Seatex Ltd
NDC Code: 76250-123

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 Handsoap

Drug Facts

Active Ingredient................Purpose

Chloroxylenol 0.40%................Antibacterial

Uses For hand washing to decrease bacteria on the skin.

Warnings
For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists 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
  • Pump into hands, wet as needed.
  • Lather vigorously for at least 15 seconds
  • Wash skin, rinse thoroughly and dry.

Inactive IngredientsWATER, SODIUM LAURETH SULFATE,LAURYL GLUCOSIDE,COCAMIDOPROPYL BETAINE, PROPYLENE GLYCOL,COCO GLUCOSIDE,GLYCERYL MONOOLEATE,SODIUM CHLORIDE,DMDM HYDANTOIN,FD and C BLUE # 1,FRAGRANCE

FOR INDUSTRIAL USE ONLY




ANTIBACTERIAL 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL40 g  in 1 kg
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
LAURYL GLUCOSIDE 
COCAMIDOPROPYL BETAINE 
PROPYLENE GLYCOL 
COCO GLUCOSIDE 
GLYCERYL MONOOLEATE 
SODIUM CHLORIDE 
DMDM HYDANTOIN 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:76250-123-044 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1NDC:76250-123-013.78 kg in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/14/2011
Labeler - Seatex Ltd (026647404)
Establishment
NameAddressID/FEIOperations
Seatex Ltd026647404manufacture

Revised: 10/2011
 
Seatex 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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