FAUNAMOR- methylene blue anhydrous, malachite green oxalate, gentian violet solution 
Aquarium Muenster Pahlsmeier GmbH

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.

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Faunamor

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.

Special warnings

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

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

Revised: 3/2020
Document Id: 52346934-a490-477a-adb1-f9461370fec1
Set id: 0f9e0b6e-fb09-46ce-a137-7645388d5aa3
Version: 5
Effective Time: 20200312
 
Aquarium Muenster Pahlsmeier GmbH