Label: ODIMOR- copper sulfate pentahydrate, malachite green oxalate solution

  • NDC Code(s): 86052-005-01, 86052-005-02
  • 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 odimor

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

    Name of the pharmaceutical product
    odimor solution

  • Applications

    Medication for ornamental fish against protozoan parasites, such as Oodinium ocellatum (coral fish disease in marine water), Oodinium pilularis (velvet disease in freshwater), Chilodonella, Costia, Trichodina, Cryptocarion and the associated secondary fungal and bacterial infections. Visible symptoms include pale grey to dark, velvetlike films and barely visible spots (smaller than those which occur in the case of Ichthyophthirius) which spread to the entire body in the latter stages of the infection. The gills stick out and the affected fish show signs of increased breathing to the point of respiratory distress.

  • Types and quantities of active substances:

    1 ml solution contains:

    20 mg copper sulfate pentahydrate

    1 mg malachite green oxalate

  • Contraindications and side effects

    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 40 drops (2 ml) of odimor to the aquarium for each 100 l of water and stir to distribute. No more than 20 drops (1 ml) of odimor should be added to the aquarium if it contains very sensitive ornamental fish (e.g. catfish or loach). Do not feed the fish. Remove the
    filter from the aquarium and place it over a 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: 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).
    Day 3: Add 20 drops (1 ml) of odimor to the aquarium for each 100 l of water and stir to distribute. No more than 20 drops (1 ml) of odimor should be added to the aquarium if it contains very sensitive ornamental fish (e.g. catfish or loach). Do not feed the fish. Remove the
    filter from the aquarium and place it over a 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 4: Follow the instructions for Day 2.
    Day 5: Follow the instructions for Day 3.
    Day 6: Follow the instructions for Day 2.
    Day 7: Do not add any medication to the water. Feed the fish as normal. Change approx. 30 % of the aquarium water.

  • Special precautions for storage

    - Keep odimor 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 administer to creatures which are used for human consumption.
    - 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.


    Date of last revision of package insert
    12/05/2015

  • Product Label

    PackageInsert

    CartonCarton2

  • INGREDIENTS AND APPEARANCE
    ODIMOR 
    copper sulfate pentahydrate, malachite green oxalate solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86052-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION20 mg  in 1 mL
    MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN CATION - UNII:AWT9R95TV1) MALACHITE GREEN OXALATE1 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86052-005-011 in 1 CARTON
    120 mL in 1 BOTTLE, GLASS
    2NDC:86052-005-021 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
    Merck GKaA342249299api manufacture