SPOTS and VELVETS Aquarium Cure Program FRESH

Manufacturer
Prodibio SAS
Effective date
2015-09-03
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:39:54

Label at a glance#

ProductSPOTS and VELVETS Aquarium Cure Program FRESH
Active ingredientGENTIAN VIOLET, MALACHITE GREEN OXALATE, ACRIFLAVINE HYDROCHLORIDE, METHYLENE BLUE
Label structure14 sections

Dosage and administration

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 ...

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

- PRODUCT NAME : Spots & Velvets Fresh

- ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

• Purified water
• Propylene glycol

- PHARMACEUTICAL FORM & CONTENTS

OTC - ACTIVE INGREDIENT SECTION

• 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

SPL UNCLASSIFIED SECTION

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

VETERINARY INDICATIONS SECTION

- 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

DOSAGE & ADMINISTRATION SECTION

Shake each vial well before use. Follow this protocol:

 Aquarium Volume
 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 A

Do not feed the fish
Vials AB together
 Day 3Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 4Do not feed the fish
Vial B
Feed the fish
No Treatment
 Day 5Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 6Do not feed the fish

Vial A

Do not feed the fish

Vial A

 Day 7Do not feed the fish
Vial B
Feed the fish
No Treatment
 Day 8Feed 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

STORAGE AND HANDLING SECTION

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

CONTRAINDICATIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DISPOSAL AND WASTE HANDLING

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

caution1caution1

How To IllustrateHow To Illustrateinsertinsert

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
METHYLENE BLUE CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86048-004-01SPOTS and VELVETS Aquarium Cure Program FRESH1 in 1 BOXKIT12
86048-005-01SPOTS and VELVETS Aquarium Cure Program FRESH0.8 mL in 1 VIAL, SINGLE-USESOLUTION2.4 mL2.5 mg in 1mL2
86048-012-01SPOTS and VELVETS Aquarium Cure Program FRESH0.6 mL in 1 VIAL, SINGLE-USESOLUTION1.2 mL2.5 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86048-004SPOTS AND VELVETS AQUARIUM CURE PROGRAM FRESH (ACRIFLAVINE HYDROCHLORIDE, GENTIAN VIOLET, MALACHITE GREEN OXALATE, METHYLENE BLUE) KIT [PRODIBIO SAS]23 package rows20150903_b902af0a-8236-4d43-926a-3f661f1ca5dc.zip
86048-005SPOTS AND VELVETS AQUARIUM CURE PROGRAM FRESH (ACRIFLAVINE HYDROCHLORIDE, GENTIAN VIOLET, MALACHITE GREEN OXALATE, METHYLENE BLUE) KIT [PRODIBIO SAS]2Unmatched20150903_b902af0a-8236-4d43-926a-3f661f1ca5dc.zip
86048-012SPOTS AND VELVETS AQUARIUM CURE PROGRAM FRESH (ACRIFLAVINE HYDROCHLORIDE, GENTIAN VIOLET, MALACHITE GREEN OXALATE, METHYLENE BLUE) KIT [PRODIBIO SAS]2Unmatched20150903_b902af0a-8236-4d43-926a-3f661f1ca5dc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACRIFLAVINE HYDROCHLORIDEACTIVE INGREDIENT1S73VW819C2
GENTIAN VIOLETACTIVE INGREDIENTJ4Z741D6O52
MALACHITE GREEN OXALATEACTIVE INGREDIENTGY1H9O33VU2
METHYLENE BLUEACTIVE INGREDIENTT42P99266K2
ACRIFLAVINEACTIVE MOIETY1T3A50395T2
GENTIAN VIOLET CATIONACTIVE MOIETY3GVJ31T6YY2
MALACHITE GREENACTIVE MOIETY12058M7ORO2
METHYLENE BLUE CATIONACTIVE MOIETYZMZ79891ZH2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86048-00486048-004-01
86048-00586048-005-01
86048-01286048-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 81 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsName fallback
generic name: GENTIAN VIOLET
Gentian VioletGENTIAN VIOLETWorld Perfumes Inc419cc9a2-bfde-a516-e063-6294a90a065c2025-10-20WarningsName fallback
generic name: GENTIAN VIOLET
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsName fallback
generic name: GENTIAN VIOLET
Sanar Naturals Gentian VioletGENTIAN VIOLETSanvall Enterprises, Inc1922518d-e49b-5010-e063-6394a90a91122024-10-31WarningsName fallback
generic name: GENTIAN VIOLET

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.