PRAZICLEANSE- praziquantel powder

PraziCleanse by

Drug Labeling and Warnings

PraziCleanse by is a Animal medication manufactured, distributed, or labeled by Fritz Industries, Sulzbach Enterprises, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Common Symptoms of Parasitic Diseases Treated

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRAZICLEANSE 
praziquantel powder

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 53745-017
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
praziquantel (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	praziquantel	190 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53745-017-01	10 in 1 BOX
1		1 g in 1 PACKET
2	NDC: 53745-017-02	20 in 1 BOX
2		1 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/26/2021

Labeler - Fritz Industries (131030991)

Establishment
Name	Address	ID/FEI	Business Operations
Sulzbach Enterprises, Inc		616846528	api manufacture, manufacture