ANTIBACTERIAL HAND - chloroxylenol soap 
Seatex Ltd

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................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 Ingredients

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

Manufactured by Seatex Ltd, Rosenberg,Texas 77471



label
cbi label
ANTIBACTERIAL HAND 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-786
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:76250-786-044 in 1 CARTON
1NDC:76250-786-013.78 kg in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/14/2011
Labeler - Seatex Ltd (026647404)
Establishment
NameAddressID/FEIBusiness Operations
Seatex Ltd026647404manufacture

Revised: 09/2011
 
Seatex Ltd