SPOTS AND VELVETS AQUARIUM CURE PROGRAM FRESH- acriflavine hydrochloride, gentian violet, malachite green oxalate, methylene blue kit

SPOTS and VELVETS Aquarium Cure Program FRESH by

Drug Labeling and Warnings

SPOTS and VELVETS Aquarium Cure Program FRESH by is a Animal medication manufactured, distributed, or labeled by Prodibio SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTRUCTIONS

PRESENTATION

SPL UNCLASSIFIED SECTION

- PRODUCT NAME : Spots & Velvets Fresh

- ACTIVE INGREDIENTS

The vials A and B contain per mL:
0.3 mg of 3,6-Diamino-10-methylacridinium chloride mixt. with 3,6-diaminoacridine (acriflavine chloride)
0.5 mg of Hexamethylpararosaniline chloride (crystal violet)
1.0 mg of N,N,N',N'-Tetramethyl-4,4'-diaminotriphenylcarbenium oxalate (malachite green oxalate)
2.5 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 0.8 mL each
2 B vials containing 0.6 mL each
1 vial of BioDigest Start containing 1.1 mL each

- 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 Ichthyophthirius, Oodinium and secondary bacterial infections caused indirectly by these protists. Visible symptoms are white spots, granular lesions or fluffy layers of pale gray. They appear on the gills, fins and may extend to the whole body. Infected fish fins retract and try to remove the parasites by rubbing against the scenery. Those whose gills are very affected have an abnormally high respiratory activity, become apathetic and lose weight quickly.

- DOSAGE AND DIRECTIONS FOR USE

Shake each vial well before use. Follow this protocol:

 Aquarium Volume

Days	60-100L	101-180L
Day 1	Do not feed the fish; Vial A	Do not feed the fish; Vials AB together
Day 2	Do not feed the fish Vial A	Do not feed the fish; Vials AB together
Day 3	Feed the fish; No Treatment	Feed the fish; No Treatment
Day 4	Do not feed the fish; Vial B	Feed the fish; No Treatment
Day 5	Feed the fish; No Treatment	Feed the fish; No Treatment
Day 6	Do not feed the fish Vial A	Do not feed the fish Vial A
Day 7	Do not feed the fish; Vial B	Feed the fish; No Treatment
Day 8	Feed the fish; No Treatment	Feed the fish; No Treatment
Day 9	Feed the fish Water change 50% of the; volume-; Add the vial BioDigest Start	Feed the fish; Water change 30% of; the volume; Add vial 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 Spots & Velvets 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 softened water may decrease the effectiveness of treatment.
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

Instructions update 2012-08.
This veterinary medicines is marketed in accordinance with the Small Animal Exception Scheme

- 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:

INGREDIENTS AND APPEARANCE

SPOTS AND VELVETS AQUARIUM CURE PROGRAM FRESH 
acriflavine hydrochloride, gentian violet, malachite green oxalate, methylene blue kit

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86048-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86048-004-01	1 in 1 BOX

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	3 VIAL, SINGLE-USE	2.4 mL
Part 2	2 VIAL, SINGLE-USE	1.2 mL

Part 1 of 2

A VIAL 
acriflavine hydrochloride, gentian violet, malachite green oxalate, methylene blue solution

Product Information
Item Code (Source)	NDC: 86048-005
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	0.5 mg  in 1 mL
MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN - UNII:12058M7ORO)	MALACHITE GREEN	1.0 mg  in 1 mL
ACRIFLAVINE HYDROCHLORIDE (UNII: 1S73VW819C) (ACRIFLAVINE - UNII:1T3A50395T)	ACRIFLAVINE	0.3 mg  in 1 mL
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)	METHYLENE BLUE	2.5 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: 86048-005-01	0.8 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 
acriflavine hydrochloride, gentian violet, malachite green oxalate, methylene blue solution

Product Information
Item Code (Source)	NDC: 86048-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACRIFLAVINE HYDROCHLORIDE (UNII: 1S73VW819C) (ACRIFLAVINE - UNII:1T3A50395T)	ACRIFLAVINE	0.3 mg  in 1 mL
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY)	GENTIAN VIOLET	0.5 mg  in 1 mL
MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN - UNII:12058M7ORO)	MALACHITE GREEN	1.0 mg  in 1 mL
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)	METHYLENE BLUE	2.5 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: 86048-012-01	0.6 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

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)