Medication Guide App

SMJ Antibacterial Hand

Dosage form: soap
Ingredients: Chloroxylenol 0.75g in 100g
Labeler: Whisk Products, Inc.
NDC Code: 65585-508

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.

SMJ Antibacterial Hand Soap

Active Ingredient
Chloroxylenol 0.75% w/w

Purpose
Skin Antimicrobial

Use
reduces amount of bacteria on hands

Warnings
For external use only.  Do not use in eyes.
Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.
Not for use on children under six months of age.
For institutional and professional use only.

Directions
  •     * Wet hands and forearms.
  •     * Apply a small amount (5 mL) or palmful to hands and forearms.
  •     * Scrub throughly for at least fifteen seconds.
  •     * Rinse completely and dry.

Inactive Ingredients
Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1


SMJ ANTIBACTERIAL HAND 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-508
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chloroxylenol (Chloroxylenol) Chloroxylenol0.75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
Trolamine Lauryl Sulfate 
DMDM Hydantoin 
FD&C Yellow No. 5 
FD&C Blue No. 1 
Lauric Diethanolamide 
Product Characteristics
Colorgreen (green, dispensed as white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65585-508-014 BAG (BAG) in 1 BOX
11000 g in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/05/2012
Labeler - Whisk Products, Inc. (834270639)
Establishment
NameAddressID/FEIOperations
Whisk Products, Inc.834270639manufacture

Revised: 01/2012
 
Whisk 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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