Antibacterial Skin Cleanser 82

Dosage form: soap
Ingredients: Chloroxylenol 1g in 100g
Labeler: Penco Products, Inc.
NDC Code: 42497-822

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.

Active Ingredient
Chloroxylenol 1% w/w

Purpose
Health Care Personnel Hand Wash

Uses
  • Hand Wash to help reduce bacteria that cause disease
  • Repeated usage suggested

Warnings
For external use only.
Keep out of reach of children.
Avoid contact with eyes and mouth.
If redness or irritation develops, discontinue use immediately.  If condition persists for more than 72 hours, consult a physician.
Not for use on children under 6 months of age.

Directions
  • Wash hands and forearms.
  • Apply 5 mL of product to hands.
  • Scrub well for 30 seconds.
  • Rinse and repeat.

Inactive Ingredients
Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene Acrylates/Copolymer, Tetrasodium EDTA, Citric Acid

In Case of Emergency
Call: (800) 228-5635  ext. 167

ANTIBACTERIAL SKIN CLEANSER 82 
antibacterial hand soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42497-822
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chloroxylenol (Chloroxylenol) Chloroxylenol1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Laureth Sulfate 
Isopropyl Alcohol 
Edetate Sodium 
Citric Acid Monohydrate 
Lauric Diethanolamide 
Sodium C14-16 Olefin Sulfonate 
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42497-822-14503 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33303/04/2010
Labeler - Penco Products, Inc. (808679773)

Revised: 03/2010
 
Penco Products, Inc.

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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