Label: FAUNAMOR- methylene blue anhydrous, malachite green oxalate, gentian violet solution

  • NDC Code(s): 86052-007-01, 86052-007-02
  • Packager: Aquarium Muenster Pahlsmeier GmbH
  • 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 March 12, 2020

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

  • Information and directions on the use of faunamor

    Name and address of the pharmaceutical company and manufacturer
    Aquarium Münster Pahlsmeier GmbH, Galgheide 8, D-48291 Telgte, Germany

    Name of the pharmaceutical product
    faunamor solution

  • Applications

    Medication for ornamental fish for the treatment of Ichthyophthirius (“white spot disease”) and the attendant bacterial infections.   chthyophthirius is one of the most common infections in ornamental fish. Visible symptoms include white spots resembling grains of sand on the gills, fins and the whole body which can spread out over wide areas. Infected fish will clamp their fins and try to rub against rough   surfaces to get rid of the parasites. Fishes with a heavy infestation on the gills will quickly become lethargic and suffer rapid weight loss.

  • Types and quantities of active substances:

    1 ml of solution contains:
    2,5 mg Methylthionine chloride
    1,0 mg Malachitgreen oxalate
    0,5 mg Methylrosaniline Chloride
    0,3 mg Acriflavine chloride

  • Types and quantities of active substances:

    No known contraindications or side effects. Should you notice side effects in your ornamental fish, please inform your vet or pharmacist.

  • Species

    Ornamental fish

  • Dosage instructions and method of administration

    Shake well before use. Follow the instructions below unless prescribed otherwise:
    Day 1:        Add 20 drops (1 ml) of faunamor to the aquarium for each 100 l of water and stir to distribute. In severe cases the dose can be   doubled as long as there are no extremely delicate ornamental fish in the aquarium (e.g. catfish). Do not feed the fish. Remove the filter from the aquarium and place it over a separate container to continue running in order to keep the microorganisms in the filter. Oxygenate the aquarium water. If the water cannot be oxygenated without operating the filter then we recommend running the filter without filtration media in order to ensure sufficient water circulation. In this case keep the filtration media cool in a container with aquarium water.
    Day 2:        Add 20 drops (1 ml) of faunamor to the aquarium for each 100 l of water and stir to distribute. Do not feed the fish.
    Day 3:        Do not add any medication to the water. Feed the fish as normal. Put the filter back into operation. If the filtration media has      been stored separately then the water must not be put back in the aquarium. In this case partially wash the filtration media out with  lukewarm water (not too thoroughly in order to retain some of the microorganisms).
    Days 4 - 6: Do not add any medication to the water. Feed the fish as normal.
    Day 7:        Follow the instructions for Day 1.
    Day 8:        Do not add any medication to the water. Feed the fish as normal. Change approx. 30 % of the aquarium water. Put the filter back into operation. If the filtration media has been stored separately then the water must not be put back in the aquarium. In this case partially wash the filtration media out with lukewarm water (not too thoroughly in order to retain some of the microorganisms).

  • Special precautions for storage

    - Keep faunamor out of direct light. Store in its original packaging.

  • KEEP OUT OF REACH OF CHILDREN

    - Keep out of reach of children.

  • Special warnings

    • May be unsuitable for invertebrates. Snails, mussels, shrimps, corals, etc. should therefore be excluded from the treatment for their own   safety.
    • For ornamental fish. Do not use on creatures which are used to obtain food.
    • The water will change colour due to the active agents but will return to normal again after a few days.
    • Any ultraviolet light systems fitted in the tank must be turned off during the treatment.
    • Do not use after the use-by date has expired.
  • Special precautions for the disposal of unused pharmaceuticals

    Take unused medical products and unfinished containers of medical products to the designated collection points.

  • Product Label

    Instructions

    Carton

    Carton2

  • INGREDIENTS AND APPEARANCE
    FAUNAMOR 
    methylene blue anhydrous, malachite green oxalate, gentian violet solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86052-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLENE BLUE ANHYDROUS (UNII: 8NAP7826UB) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE2.5 mg  in 1 mL
    MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN CATION - UNII:AWT9R95TV1) MALACHITE GREEN OXALATE1.0 mg  in 1 mL
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET0.5 mg  in 1 mL
    ACRIFLAVINE HYDROCHLORIDE (UNII: 1S73VW819C) (ACRIFLAVINE - UNII:1T3A50395T) ACRIFLAVINE HYDROCHLORIDE3 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86052-007-011 in 1 CARTON
    120 mL in 1 BOTTLE, GLASS
    2NDC:86052-007-021 in 1 CARTON
    2100 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/12/2020
    Labeler - Aquarium Muenster Pahlsmeier GmbH (317318368)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigma-Aldrich Production GMBH480945463api manufacture