Label: API FUNGUS CURE- acriflavine powder
- NDC Code(s): 17163-116-16
- Packager: MARS FISHCARE NORTH AMERICA, INC.
- 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 December 18, 2020
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Direction for Use:
For best results, remove activated carbon or filter cartridge from filter and continue aeration.
For each 10 gallons (38 L) of water, empty one packet directly into aquarium.
Repeat dose after 48 hours.
Wait another 48 hours then change 25% of the aquarium water and add fresh activated carbon or replace filter cartridge.
Note; This medication will discolor water and may stain aquarium sealant and ornaments.
Use API BIO-CHEM ZORB or activated carbon 48 hours after final treatment to remove color from water.
This package treats up to 100 gallons. Two doses required for full course of treatment
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INDICATIONS & USAGE
Diagnostic Chart
Fungus: White, "cottony" tufts or patches appear on the mouth, skin and fins. Fungus often starts with isolated pale or white patches on skin. Left untreated, fungal infections spread rapidly across whole body.
Mouth Fungus: Common bacterial infection that affects the mouth and other soft tissue. Fungus-like in appearance with red periphery. If left untreated, severe erosion and lesions will develop.
Body Slime and Eye Cloud: Eyes develop a white haze and or protrude from the head. Slimy patches appear on the body. Fish may scratch on objects and exhibit rapid breathing.Infection may cause abnormal osmotic function resulting in fluid accumulation to the eyes and/or body.
Fin and Tail Rot: Fins appear ragged and split. In severe cases, fins and tail are almost completely eroded. Secondary fungal infections, observed as white, "cottony" growth, commonly occur.
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WARNINGS AND PRECAUTIONS
KEEP OUT OF REACH OF CHILDREN.
For aquarium use only.
Not for human consumption or for treatment of fish intended for human consumption.
Avoid contact with skin and eyes.
May cause irritation.
! WARNING:
This product can expose you to chemicals including Silica, crystalline, which is none to the State of California to cause cancer.
For more information go to www.P65Warnings.ca.gov.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
API FUNGUS CURE
acriflavine powderProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17163-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACRIFLAVINE HYDROCHLORIDE (UNII: 1S73VW819C) (ACRIFLAVINE - UNII:1T3A50395T) ACRIFLAVINE HYDROCHLORIDE 30 mg in 2 g MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN - UNII:12058M7ORO) MALACHITE GREEN OXALATE 3 mg in 2 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17163-116-16 20 g in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/03/2011 Labeler - MARS FISHCARE NORTH AMERICA, INC. (049630700) Establishment Name Address ID/FEI Business Operations MARS FISHCARE NORTH AMERICA, INC. 049630700 manufacture, repack, relabel, api manufacture Establishment Name Address ID/FEI Business Operations Unilab Chemicals and Pharmaceuticals Private Limited 915893696 api manufacture