Label: SPOTS AND VELVETS AQUARIUM CURE PROGRAM SALT- ethacridine lactate, gentian violet, malachite green oxalate, methylene blue kit
- NDC Code(s): 86048-006-01, 86048-007-01, 86048-013-01
- Packager: Prodibio SAS
- Category: OTC ANIMAL DRUG LABEL
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 2, 2015
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- Official Label (Printer Friendly)
- INSTRUCTIONS
- PRESENTATION
- SPL UNCLASSIFIED SECTION
-
- ACTIVE INGREDIENTS
The vials A and B contain per mL:
• 0.10 mg of 6,9-Diamino-2-ethoxyacridine-DL-lactate monohydrate (ethacridine lactate)
• 0.05 mg of Hexamethylpararosaniline chloride (crystal violet)
• 1.25 mg of N,N,N′,N′-Tetramethyl-4,4′-diamino triphenylcarbenium oxalate (malachite green oxalate)
• 0.10 mg of 3,7-bis(Dimethylamino)phenazathionium chloride (methylene blue)
The BioDigest Start vial contains nitrifying and denitrifying living bacteria that have not been genetically modified. - - EXCIPIENTS
- - PHARMACEUTICAL FORM & CONTENTS
- - MANUFACTURER
-
USAGE
- THERAPEUTIC INDICATIONS
Product intended only for the treatment of ornamental fish with the so-called "white spots" and "velvet" diseases, mainly caused by Oodinium ocellatum, Cryptobia, Cryptocarion… Visible symptoms are fluffy layers of gray / light gray, or tiny white spots on the gills, fins and the rest of the body in later stages of the infection. Sick fish breathe heavily and with difficulty; they spreads their gills wide. -
- DOSAGE AND DIRECTIONS FOR USE
Shake each vial well before use. Follow this protocol:
Days 60-100L 101-180L Day 1 Do not feed the fish
Vial ADo not feed the fish
Vials A B togetherDay 2 Do not feed the fish
Vial B
Do not feed the fish
Vials ADay 3 Feed the fish
No TreatmentFeed the fish
No TreatmentDay 4 Do not feed the fish
Vial ADo not feed the fish
Vials AB togetherDay 5 Do not feed the fish Vial B
Feed the fish
No TreatmentDay 6 Feed the fish
No TreatmentFeed the fish
Water change:
30% of the volume
Add the vial
BioDigest StartDay 7 Do not feed the fish
Vial A- Day 8 Feed the fish
No Treatment- Day 9 Feed the fish
Water change 50% of the
volume-
Add the vial BioDigest Start- Spots & Velvets Salt is well tolerated by invertebrates, and it is not necessary to remove corals from the aquarium during the treatment. Ensure a good water flow and a good 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
- PRECAUTIONS- CONTRAINDICATIONS & INTERACTIONS
- - UNWANTED SIDE EFFECTS
- - SPECIAL PRECAUTIONS
- SPL UNCLASSIFIED SECTION
- - Special precautions for the disposal of unused pharmaceuticals
- Package Labeling:
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INGREDIENTS AND APPEARANCE
SPOTS AND VELVETS AQUARIUM CURE PROGRAM SALT
ethacridine lactate, gentian violet, malachite green oxalate, methylene blue kitProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86048-006 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86048-006-01 1 in 1 BOX Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 3 VIAL, SINGLE-USE 4.8 mL Part 2 2 VIAL, SINGLE-USE 2.4 mL Part 1 of 2 A VIAL
ethacridine lactate, gentian violet, malachite green oxalate, methylene blue solutionProduct Information Item Code (Source) NDC:86048-007 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET 0.05 mg in 1 mL MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN - UNII:12058M7ORO) MALACHITE GREEN 1.25 mg in 1 mL ETHACRIDINE LACTATE (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R) ETHACRIDINE 0.10 mg in 1 mL METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE 0.10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86048-007-01 1.6 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/24/2015 Part 2 of 2 B VIAL
ethacridine lactate, gentian violet, malachite green oxalate, methylene blue solutionProduct Information Item Code (Source) NDC:86048-013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHACRIDINE LACTATE (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R) ETHACRIDINE 0.10 mg in 1 mL GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET 0.05 mg in 1 mL MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN - UNII:12058M7ORO) MALACHITE GREEN 1.25 mg in 1 mL METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE 0.10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86048-013-01 1.2 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/24/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/24/2015 Labeler - Prodibio SAS (647909431)