Label: METROCLEANSE- metronidazole powder

  • NDC Code(s): 53745-016-01, 53745-016-02
  • 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:

    Common Symptoms of Parasitic Diseases.

    image 1image 2image 3

    ICK: Small white spots may cover the entire body; fish may rub or scratch against bottom
    PROTOZOAN VLVET: Tiny yellowish spots loss of color, rubbing or scratching on bottom
    EXTERNAL PARASITES: Extra mucous, visible spots or worms, rapid breathing, flashing, scratching or rubbing on rocks

  • PREPARATIONS:

    Use of a hospital tank is recommended. 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.

  • DIRECTIONS:

    Broadcast Instructions: Remove all invertebrates prior to dosing if using broadcast method. Use 1 packet of MetroCleanse mixed per tablespoon of normal food (adding some water if food is dry). Feed medicated food mix daily until symptoms disappear or up to three weeks. Refrigerate or
    freeze leftover mix between dosing/feeding. No adjustment of filtration needed when used with food.

    MetroCleanse can easily be removed from system by adding carbon. MetroCleanse is effective against internal and external infections regardless of dosing method.

  • ACTIVE INGREDIENT:

    Each packet contains 200 mg Metronidazole.

  • WARNING

    This product contains chemicals, including Metronidazole, which is known to the State of California to cause cancer.

  • 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


    MetroCleanse


    Provides Fast Relief from Parasitic Diseases & Infections


    Antibiotic and anti-parasitic treatment for common protozoan and bacterial infections such as freshwater and saltwater Ich, Hexamita, and Oodinium. Effective agaisnt internal parasitic and bacterial infections.


    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

    10 pack label

  • PRINCIPAL DISPLAY PANEL

    20 pack label

  • INGREDIENTS AND APPEARANCE
    METROCLEANSE 
    metronidazole powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:53745-016
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE200 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:53745-016-0110 in 1 BOX
    11 g in 1 PACKET
    2NDC:53745-016-0220 in 1 BOX
    21 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2021
    Labeler - Fritz Industries (131030991)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sulzbach Enterprises, Inc616846528api manufacture, manufacture