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Mystic Foaming Hand Sanitizer

Dosage form: solution
Ingredients: BENZALKONIUM CHLORIDE 0.1mL in 100mL
Labeler: Kay Chemical Company
NDC Code: 63146-117

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.

Drug Facts

Active ingredient

Benzalkonium chloride 0.1%

Purpose

Antiseptic handwash

Uses
  • For handwashing to decrease bacteria on the skin

Warnings
  • For external use only

Do not use
  • In eyes

When using this product
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop

Stop use and ask a doctor if
  • skin irritation or redness occurs 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
  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry

Other information
  • for additional information, see Material Safety Data Sheet (MSDS)
  • for emergency medical information in USA call 1-800-391-1504

Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, FDC Red 40, FDC Blue 1

Questions?

Call 1-800-532-7732

Representative label and principal display panel

SSDC

NDC 63146-117-03


MYSTIC

Foaming Hand Sanitizer

Benzalkonium chloride 0.1%


Net Contents: 750 mL/25 US fl oz

Distributed by:  SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732

Copyright, 2010 Kay Chemical Company  All Rights Reserved

749436-00 - 749436/7300/0510


1112021


MYSTIC FOAMING HAND SANITIZER 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Isopropyl alcohol 
Propylene glycol 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:63146-117-03750 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/29/2010
Labeler - Kay Chemical Company (003237021)

Revised: 12/2010
Document Id: d85bc2f1-68aa-4d72-a597-0465dd684b09
Set id: 229a1d8d-8ece-492f-a296-295ce075a4c1
Version: 4
Effective Time: 20101206
 
Kay Chemical Company

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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