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Mystic

Medically reviewed on March 2, 2018

Dosage form: solution
Ingredients: BENZALKONIUM CHLORIDE 5mg in 1mL
Labeler: Kay Chemical Company
NDC Code: 63146-304

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 0.5%

Purpose

Antiseptic handwash

Uses
  • for handwashing to decrease bacteria on the skin

Warning ´╗┐For external use only

Do not use
  • in eyes

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

Stop use and ask a docotr 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
  • Wet hands and forearms
  • Dispense a palmful of product to hands
  • Scrub hands and forearms for 20 seconds
  • Rinse thoroughly and dry

Other information
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA call 1-800-328-0026

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

Questions? Call 1-800-532-7732

Representative Label and Principal Display Panel

NDC 63146-304-10

SSDC

Sustainable Solutions

MYSTIC™

Foaming Anti-Bacterial Hand Soap

Jabón para manos con espuma antibacterial

Active Ingredient

Benzalkonium chloride 0.5%

1110489

Net Content/Contenido Neto: 1250 mL/42.3 US fl. oz.

Distributed by:

SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732

©2016 Kay Chemical Company All Rights Reserved

Made in United States

765697-00 765697/7300/0316

MYSTIC 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-304
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
POTASSIUM HYDROXIDE 
PEG-12 DIMETHICONE (300 CST) 
MEDIUM-CHAIN TRIGLYCERIDES 
METHYL GLUCETH-20 
MYRISTIC DIISOPROPANOLAMIDE 
CITRIC ACID MONOHYDRATE 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) 
PHENOXYETHANOL 
MYRISTAMINE OXIDE 
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
GLYCERIN 
POLYETHYLENE GLYCOL 8000 
HEXYLENE GLYCOL 
WATER 
COCAMINE OXIDE 
Packaging
#Item CodePackage Description
1NDC:63146-304-10750 mL in 1 BOTTLE, PLASTIC
2NDC:63146-304-081250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/11/2016
Labeler - Kay Chemical Company (003237021)

 
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 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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