Label: BACTERIA AND FUNGI AQUARIUM CURE PROGRAM FRESH- acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous kit

  • NDC Code(s): 86048-008-01, 86048-009-01, 86048-014-01
  • Packager: Prodibio SAS
  • 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 September 3, 2015

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

  • INSTRUCTIONS

  • PRESENTATION

  • SPL UNCLASSIFIED SECTION

    -PRODUCT NAME : Bacteria & Fungi Fresh

  • - 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 freshwater fish. Bacteria & Fungi Fresh 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 Fresh 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 snails and shrimps cannot withstand Bacteria & Fungi Fresh, and must be removed from the aquarium before beginning the treatment. Some filiform plants can be damaged by the treatment. The simultaneous use of water treatment products may decrease the effectiveness of Bacteria & Fungi Fresh. Do not use with another treatment.

  • - UNWANTED SIDE EFFECTS

    None known. Should you notice any side effects, please let us know (info@prodibio.fr).
    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.

    Keep out of the reach of children.

  • SPL UNCLASSIFIED SECTION

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

    Instructions update 2012-08.

  • - 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:

    box

    caution1

    How To Illustrate

    insert

  • INGREDIENTS AND APPEARANCE
    BACTERIA AND FUNGI AQUARIUM CURE PROGRAM FRESH 
    acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous kit
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86048-008
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86048-008-011 in 1 BOX
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 VIAL, SINGLE-USE 3.9 mL
    Part 22 VIAL, SINGLE-USE 2.0 mL
    Part 1 of 2
    A VIAL 
    acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous solution
    Product Information
    Item Code (Source)NDC:86048-009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACRIFLAVINE HYDROCHLORIDE (UNII: 1S73VW819C) (ACRIFLAVINE - UNII:1T3A50395T) ACRIFLAVINE2.00 mg  in 1 mL
    METHYL ORANGE (UNII: 6B4TC34456) (METHYL ORANGE - UNII:6B4TC34456) METHYL ORANGE0.26 mg  in 1 mL
    ethacridine lactate (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R) ethacridine lactate4.00 mg  in 1 mL
    METHYLENE BLUE ANHYDROUS (UNII: 8NAP7826UB) (METHYLENE BLUE - UNII:T42P99266K) METHYLENE BLUE2.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86048-009-011.3 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2015
    Part 2 of 2
    B VIAL 
    acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous solution
    Product Information
    Item Code (Source)NDC:86048-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACRIFLAVINE HYDROCHLORIDE (UNII: 1S73VW819C) (ACRIFLAVINE - UNII:1T3A50395T) ACRIFLAVINE HYDROCHLORIDE2.00 mg  in 1 mL
    methyl orange (UNII: 6B4TC34456) (methyl orange - UNII:6B4TC34456) methyl orange0.26 mg  in 1 mL
    ethacridine lactate (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R) ETHACRIDINE4.00 mg  in 1 mL
    METHYLENE BLUE ANHYDROUS (UNII: 8NAP7826UB) (METHYLENE BLUE - UNII:T42P99266K) METHYLENE BLUE2.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86048-014-011.0 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2015
    Labeler - Prodibio SAS (647909431)