SPOTS AND VELVETS AQUARIUM CURE PROGRAM SALT- ethacridine lactate, gentian violet, malachite green oxalate, methylene blue 
Prodibio SAS

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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SPOTS & VELVETS Aquarium Cure Program SALT

INSTRUCTIONS

PRESENTATION

-PRODUCT NAME : Spots & Velvets Salt

- 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

• Purified water
• Propylene glycol

- PHARMACEUTICAL FORM & CONTENTS

• 3 A vials containing 1.6 mL
• 2 B vials containing 1.2 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 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 1Do not feed the fish
Vial A
Do not feed the fish
Vials A B 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
Do not feed the fish
Vials AB together
 Day 5Do not feed the fish

Vial B

Feed the fish
No Treatment
 Day 6Feed the fish
No Treatment
Feed the fish
Water change:
30% of the volume
Add the vial
BioDigest Start
 Day 7Do not feed the fish
Vial A
-
 Day 8Feed 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

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

The simultaneous use of water treatment products may decrease the effectiveness of Spots & Velvets Salt.
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.

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 od drugs not entirely used up at the respective collecting points

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

Package Labeling:

boxcaution1How To Illustrateinsert

SPOTS AND VELVETS AQUARIUM CURE PROGRAM SALT 
ethacridine lactate, gentian violet, malachite green oxalate, methylene blue kit
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86048-006
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86048-006-011 in 1 BOX
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 VIAL, SINGLE-USE 4.8 mL
Part 22 VIAL, SINGLE-USE 2.4 mL
Part 1 of 2
A VIAL 
ethacridine lactate, gentian violet, malachite green oxalate, methylene blue solution
Product Information
Item Code (Source)NDC:86048-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET0.05 mg  in 1 mL
MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN - UNII:12058M7ORO) MALACHITE GREEN1.25 mg  in 1 mL
ETHACRIDINE LACTATE (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R) ETHACRIDINE0.10 mg  in 1 mL
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE0.10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86048-007-011.6 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 
ethacridine lactate, gentian violet, malachite green oxalate, methylene blue solution
Product Information
Item Code (Source)NDC:86048-013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETHACRIDINE LACTATE (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R) ETHACRIDINE0.10 mg  in 1 mL
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET0.05 mg  in 1 mL
MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN - UNII:12058M7ORO) MALACHITE GREEN1.25 mg  in 1 mL
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE0.10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86048-013-011.2 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)

Revised: 9/2015
Document Id: 67513ccc-14b4-47fb-8252-98921f1eb460
Set id: 9b0a221b-bd0c-467e-9777-4de0d571c02c
Version: 3
Effective Time: 20150902
 
Prodibio SAS