Animal NDC 86048-010-01 Bacteria And Fungi Aquarium Cure Program Salt
Acriflavine Hydrochloride, Methyl Orange, Ethacridine Lactate, Methylene Blue Anhydrous

Animal Product Information

Field Name Field Value
Animal NDC Code 86048-010-01
Proprietary Name Bacteria And Fungi Aquarium Cure Program Salt What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Acriflavine Hydrochloride, Methyl Orange, Ethacridine Lactate, Methylene Blue Anhydrous What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Prodibio Sas
Product Type Otc Animal Drug
Usage Information
    Invertebrates such as corals, snails, anemones and shrimps cannot withstand Bacteria & Fungi Salt, and must be removed from the aquarium before beginning the treatment. The simultaneous use of water treatment products may decrease the effectiveness of Bacteria & Fungi Salt. Do not use with another treatment.
Active Ingredient(s)
  • Ethacridine Lactate
  • Acriflavine Hydrochloride
  • Methylene Blue Anhydrous
  • Methyl Orange
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Bacteria And Fungi Aquarium Cure Program Salt Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Instructions




Other



- PRODUCT NAME: Bacteria & Fungi Salt

This veterinary medicines is marketed in accordinance with the Small Animal Exception Scheme

Instructions update 2012-08.


- Active Ingredients



- ACTIVE INGREDIENTS
The vials A and B contain per mL:
• 2.00 mg of 3,6-diamino-10-methylacridinium chloride mixt. with 3,6-diaminoacridine (acriflavine chloride)
• 0.26 mg of 4-(4-dimethylaminophenylazo)-benzenesulfonate sodium salt (methyl orange)
• 4.00 mg of 6,9-diamino-2-ethoxyacridine-DL-lactate monohydrate (ethacridine lactate)
• 2.75 mg of 3,7-bis(dimethylamino)phenazathionium chloride (methylthionine chloride)
The BioDigest Start vial contains nitrifying and denitrifying living bacteria that have not been genetically modified.


- Excipients



• Purified water
• Propylene glycol


- Pharmaceutical Form & Contents



• 3 A vials containing 1.3 mL
• 2 B vials containing 1.0 mL
• 1 vial of BioDigest Start containing 1.1 mL


- Manufacturer



Vials A and B : product manufactured for PRODIBIO,
under GMP, by Aquarium Münster Pahlsmeier GmbH,
Galgheide 8, D-48291 Telgte, GE
Vial of BioDigest Start : PRODIBIO
3, Allée des Maraîchers, 13013 Marseille, France


Usage



- THERAPEUTIC INDICATIONS
Product intended only for the treatment of ornamental saltwater fish. Bacteria & Fungi Salt has a wide spectrum of action and treats a large number of diseases caused by bacteria or fungi. Visible symptoms may be whitish or yellowish secretions, ulcers, skin inflammations, bleeding, scale loss, fin decomposition, bulging eyes, cotton fluff, swollen belly, or unusual oscillatory movements of the fish. Bacteria & Fungi Salt can be used when the diagnosis of the disease is neither possible nor obvious.


- Dosage And Directions For Use



Shake each vial well before use. Follow this protocol:

 Days 60-100L 101-180L
 Day 1Do not feed the fish
Vial A
Do not feed the fish
Vials AB together
 Day 2

Do not feed the fish

Vial B

Do not feed the fish
Vials A
 Day 3Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 4Do not feed the fish
Vial A
Feed the fish
No Treatment
 Day 5Do not feed the fish

Vial B

Feed the fish
No Treatment
 Day 6Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 7Do not feed the fish
Vial A

Do not feed the fish

​Vials AB at the same time

 Day 8Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 9

Water change:
-50% of the volume

Feed the fish

No Treatment
Add the vial of

BioDigest Start

Water Change:

-30% of the volume
Feed the fish

No Treatment

Add the vial of
BioDigest Start

Ensure a good flow and good water oxygenation. To protect the biological filter, during the treatment days, remove the bacterial support material from the filter. Run it in another aquarium if possible, or at least keep it moist with water in a container. Reinsert the support material on the days the fish are fed, after briefly rinsing it with clean water.


- Preservation



Keep the vials in the original packaging away from direct sunlight and heat sources.
Do not use after the expiration date printed on the box and vials.


Precautions- Contraindications & Interactions



Invertebrates such as corals, snails, anemones and shrimps cannot withstand Bacteria & Fungi Salt, and must be removed from the aquarium before beginning the treatment. The simultaneous use of water treatment products may decrease the effectiveness of Bacteria & Fungi Salt. Do not use with another treatment.


- Unwanted Side Effects



None known. Should you notice any side effects, please let us know ([email protected]).
The water coloration is due to the active ingredients and will disappear after a few days.


- Special Precautions



Sources of UV radiation and skimmers must be stopped during the treatment.
Product for ornamental fish only, do not use with fish intended for consumption.


- Special Precautions For The Disposal Of Unused Pharmaceuticals



Dispose old drugs not entirely used up at the respective collecting points

Disposal advice: after use, vials must be thrown in recyclable glass rubbish


Package Labeling:




* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.