Label: PRAZICLEANSE- praziquantel powder

  • NDC Code(s): 53745-017-01, 53745-017-02
  • Packager: Fritz Industries
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 6, 2021

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Common Symptoms of Parasitic Diseases Treated

    image 1image 2image 3

    Skin Flukes: Extra mucous, visible spots or worms, flashing, scratching or rubbing on rocks

    Wasting Disease: Clamped fins, weight loss, lethargy, deformity

    Gill Flukes: Discolored, swollen gills, rapid breathing, gasping at surface

    PraziCleanse is a safe anti-parasitic treatment to control unwanted parasites. Our easy-to-use packet dosing system is effective against skin and gill flukes, tapeworms, flatworms, and turbellarians. Works in both fresh and saltwater systems without affecting biological filtration when used as directed. PraziCleanse is safe for use with most invertebrates.

  • PREPARATIONS:

    No water changes, pH or temperature adjustments necessary if readings are in ideal range (Freshwater pH 6.4 - 7.6 / Saltwater 8.0 - 8.4, temperature 68° to 82° F). Remove all chemical filtration (carbon, ion exchange resins) before and during use. Turn off UV sterilizer if present during treatment. Aeration and water flow should be maintained. In marine aquariums turn off protein skimmer during treatment; resume use after completion of treatment. Note: Fritz PraziCleanse will not color or cloud aquarium water. Use of a hospital tank is recommended.

  • DIRECTIONS:

    Add one packet PraziCleanse per 20 gallons. After 5 days, perform a 25% water change and repeat treatment. Discontinue use of skimmer, UV sterilizers, carbon and other adsorptive resins during treatment. NOTE: Not safe for use in marine systems with tube worms or feather dusters.

  • ACTIVE INGREDIENT:

    Each packet contains 190 mg praziquantel.

  • PRECAUTIONS:

    KEEP OUT OF REACH OF CHILDREN

  • WARNING:

    THIS PRODUCT IS INTENDED FOR THE EXCLUSIVE USE WITH ORNAMENTAL ORGANISMS INDICATED AND IS NOT INTENDED FOR USE WITH OTHER ANIMALS, HUMANS, OR FISH FOR HUMAN CONSUMPTION

  • SPL UNCLASSIFIED SECTION

    FRITZ


    PraziCleanse


    Provides Fast Relief from Parasitic Diseases


    Safe and effective prevention, treatment and control of flukes, tapeworms, flatworms and turbellarians in freshwater and saltwater aquariums.  Will not negatively affect biological filtration.


    Net Contents: 10-0.035 oz (1g) Powder Packets


    FRITZ AQUATICS
    Distributed by: Fritz Industries, Inc.
    Mesquite, TX 75149
    MADE IN USA
    www.fritzaquatics.com
    Questions or Comments?
    Email: info@fritzaquatics.com

  • PRINCIPAL DISPLAY PANEL

    PraziCleanse 10 pack

  • PRINCIPAL DISPLAY PANEL

    PraziCleanse 20 pack

  • INGREDIENTS AND APPEARANCE
    PRAZICLEANSE 
    praziquantel powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:53745-017
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    praziquantel (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) praziquantel190 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53745-017-0110 in 1 BOX
    11 g in 1 PACKET
    2NDC:53745-017-0220 in 1 BOX
    21 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/26/2021
    Labeler - Fritz Industries (131030991)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sulzbach Enterprises, Inc616846528api manufacture, manufacture