Label: PARASITE-S - formaldehyde liquid 

  • Label RSS
  • NDC Code(s): 50378-010-01, 50378-010-05, 50378-010-10, 50378-010-99
  • Packager: Western Chemical Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/09

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  • DESCRIPTION

    Description

    PARASITE-S is the aqueous solution of formaldehyde gas (this is equivalent to formalin 37% or
    37grams of formaldehyde in 100mLof solution). U.S.P. grade PARASITE-S contains not less than
    37% (by weight) of formaldehyde gas per weight of water and 6 to 14% methanol. In solution, formaldehyde
    is present chiefly as HO(CH20)H. Its molecular weight is 30.93. PARASITE-S is readily
    miscible with water, methanol, and ethanol and is slightly soluble in ether. It is a clear, colorless
    liquid (Heyden Newport Chemical Corporation, 1961).

    Fish and Shrimp Toxicity Studies

    The toxicity of PARASITE-S was measured by standard methods in laboratory bioassays with
    rainbow trout, Atlantic salmon, lake trout, black bullhead, channel catfish, green sunfish, bluegill,
    smallmouth bass, largemouth bass and striped bass. The 3,6,24 and 96-hour LC50 (lethal
    concentration for 50% of the animals) values for trout range from 1,230 to 100 μL/L (455 to 37 ppm
    formaldehyde); for catfish, from 495 to 65.8 μL/L (183 to 24 ppm formaldehyde); for bluegill,
    from 1,230 to 100 μL/L (455 to 37 ppm formaldehyde); for catfish, from 495 to 65.8 μL/L (183 to 24 ppm formaldehyde);
    for bluegill, from 2,290 to 100 μL/L (847 to 37 ppm formaldehyde); for largemouth bass,
    the values for 6 to 96-hour LC50 range from 1,030 to 143 μL/L (381 to 53 ppm formaldehyde) (Bill et al. 1977)
    and for striped bass the values for 6 to 96-hour LC50 range from 940 to 30 μL/L (347 to 11 ppm formaldehyde)
    (Bills, Marking and Howe-1993).  The 24, 48, 72 and 96 hour LC50 values for penaeid shrimp range
    from 712 to 250 µL/L (ppm) (Johnson. 1974 and Williams, 1980).


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  • Indications for Use

    1. Parasiticide for Finfish: for the control of external protozoa (Chilodonella spp., Ichthyobodo spp., Epistylis spp., Ichthyophthirius spp., Ambiphrya spp. and Trichodina spp.), and the monogenetic trematode parasites (Cleidodiscus spp., Dactylogyrus spp., and Gyrodactylus spp.).
    2. Parasiticide for Penaeld Shrimp: for the control of external protozoan parasites (Bodo spp., Epistylis spp., and Zoothamnium spp.).
    3. Fungicide for Finflsh Eggs: for the control of fungi of the family Saprolegniaceae.

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  • Directions for Use


    1. Parasiticide for Finfish
    Image of Parasite-S Table 1
    * Microliter per liter (μL/L) = parts per million (ppm).
    ** Use the lower concentration when ponds, tanks or raceways are heavily loaded with phytoplankton,
    or fish, to avoid oxygen depletion due to the biological oxygen demand created by
    decay of dead phytoplankton. Alternatively, a higher concentration might be used if dissolved
    oxygen is strictly monitored.
    *** Although the indicated concentrations are considered safe for cold and warm water finfish, a
    small number of each lot or pond to be treated should always be used to check for any unusual
    sensitivity to formalin before proceeding.
    2. Parasiticide for Penaeld Shrimp
    Image of Parasite-S Table 2
    * Microliter per liter (μL/L) = parts per million (ppm).
    ** Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved.
    Use the lower concentration when ponds, tanks or raceways are heavily loaded with phytoplankton,
    or shrimp, to avoid oxygen depletion due to the biological oxygen demand created by
    decay of dead phytoplankton. Alternatively, a higher concentration might be used if dissolved
    oxygen is strictly monitored.
    *** Treatment may be repeated in 5 to 10 days, if needed
    3. Fungicide for Finfish Eggs
    Image of Parasite-S Table 3
    * Microliter per liter (μL/L) = parts per million (ppm).
    ** Apply in constant flow water supply of incubating facilities. A preliminary bioassay should be
    conducted on a small subsample of fish eggs to determine sensitivity before treating an entire
    group. This is necessary for all species because egg sensitivity can vary with species or strain
    and the unique conditions at each facility.

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  • Methods of Application

    APPLICATION TO TANKS AND RACEWAYS -Turn off water supply, provide aeration, apply
    appropriate amount of PARASITE-S, and thoroughly dilute and mix to assure equal distribution of
    PARASITE-S. Treat for up to 1 hour for fish and up to 4 hours for penaeid shrimp, then drain the
    solution and refill the tank with fresh, well-aerated water. While tank is under treatment, adequate
    oxygen must be present to maintain the fish or shrimp. If needed. aeration should be provided to
    prevent oxygen depletion. Treatments may be repeated daily until parasite control is achieved.
    APPLICATION TO PONDS - Apply greatly diluted PARASITE-S to the pond evenly using a pump,
    sprayer, boat bailer, or other suitable device to assure even distribution. Allow PARASITE-S to dissipate
    naturally. Single treatments usually control most parasites, but may be repeated in 5 to 10 days if
    needed. Treatments for Ichthyophthirius should be made at 2-day intervals until control is achieved.
    APPLICATION TO EGG INCUBATORS - Apply PARASITE-S into a constant water supply flowing
    around the eggs. A drip or pressure system should be used and timed. Apply PARASITE-S under
    the surface of the water flow.

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  • WARNINGS

    WITHDRAWAL TIME
    Zero days.

    Warning

    Striped bass have been demonstrated to be hypersensitive to formalin; lethal toxicity has been
    noted to occur at levels approximately 2-3 times the recommended therapeutic concentration.

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  • USER SAFETY WARNINGS

    DANGER POISON

    User Safety Warnings

    Exposure to high concentrations of formaldehyde vapor causes severe respiratory irritation
    which can be life-threatening. Lower vapor levels can cause irritation to the eyes, respiratory
    tract, and skin. Swallowing formaldehyde can be life-threatening. Formaldehyde is an irritant
    when splashed on skin or Into the eyes. It can cause severe eye damage, even blindness.

    Keep out of reach of children.

    Use only with adequate ventilation.

    Keep container tightly closed when not in use.

    May aggravate a pre-existing asthmatic condition and allergic rhinitis.

    Moderate fire and explosion hazard exists when exposed to heat or flame.

    Contains methanol - cannot be made non-poisonous. Prolonged exposure to methanol has
    been associated with reproduction disorders.

    Potential Cancer Hazard: Formaldehyde vapor may be carcinogenic if inhaled. Use applicable
    safety protection. (Note: This drug, used as labeled, does not cause formaldehyde
    tissue residues in fish).

    Employers: Refer to Occupational Safety and Health Administration (OSHA) regulation 29
    CFR 1910.1048 for human safety guidance that may be applicable to your specific operation.
    OSHA’s “action level” concentration for airborne formaldehyde is 0.5 part per million
    (ppm), calculated as an 8 hour time-weighted average (TWA). Use respiratory, skin, and eye
    protection when needed (refer to OSHA’s regulation 29 CFR 1910.1048). OSHA’s airborne
    exposure limits (without use of a respirator) for formaldehyde shall not exceed 1) 0.75 part
    per million (ppm) as an 8-hour, time-weighted average (TWA) or 2) 2 parts per million (ppm)
    as a 15-minute, short term exposure limit (STEL). NOTE: The odor of formaldehyde in the air
    can generally be detected at about 0.5 to 0.8 ppm (range about 0.05 to 1 ppm).

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  • User Exposure Emergency Aid

    INHALATION (Breathing): Get medical aid immediately. Remove victim from exposure
    wearing protective clothing and respiratory protection appropriate to the type and degree of
    contamination. Move victim to fresh air immediately. If breathing is difficult, give oxygen. DO
    NOT use mouth-to-mouth respiration. If breathing has ceased, induce artificial respiration
    with the aid of a pocket mask equipped with a one-way valve or other proper respiratory
    medical device.

    INGESTION (Swallowing): DO NOT induce vomiting. If the person is conscious, dilute,
    inactivate, or absorb the formaldehyde by giving milk, activated charcoal, or water. Get
    medical help immediately. If vomiting occurs, keep head lower than hips.

    EYE CONTACT: Immediately flush eye(s) with large amounts of water for at least 15 minutes,
    lifting the lower and upper eyelids occasionally, until no evidence of chemical remains.
    Seek medical attention immediately. DO NOT allow victim to rub eyes or keep eyes closed
    for burns to eyes may have a delayed effect.

    SKIN CONTACT: Remove contaminated clothing (including shoes) immediately. Wash affected
    area of body with soap and large amounts of water until no evidence of chemical
    remains (at least 15 minutes). If there are chemical burns, or appreciable eye or respiratory
    irritation, get medical help immediately.

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  • Precautions

    Store PARASITE-S indoors away from direct sunlight, heat, sparks, and open flames, and
    ventilate storage area. Do not subject PARASITE-S to temperatures below 40°F (4.4°C).
    PARASITE-S subjected to temperatures below 40°F causes the formation of paraformaldehyde,
    a substance which is toxic to fish. Paraformaldehyde can be recognized as a white
    precipitate at the bottom or on the walls of the container.

    Tolerance to PARASITE-S may vary with strain and species of fish, eggs and shrimp. While
    the indicated concentrationaare considered safe for the indicated use, a smallnumber of
    each lot to be treated should be used to check for any unusual sensitivity to PARASITE-S
    before proceeding.

    Under some conditions, fish or penaeid shrimp may be stressed by normal treatment concentrations.
    Heavily parasitized or diseased fish or penaeid shrimp often have a greatly
    reduced tolerance to PARASITE-S. Such animals do not tolerate the normal tank treatment
    regimen the first time they are treated. Therefore, time and dosage may need to be reduced.
    If they show evidence of distress (by piping at the surface), the solution should be removed
    and replaced with fresh, well aerated water. Careful observations should always be made
    throughout the treatment period whenever tank or raceway treatments are made. Treatment
    should never exceed 1 hour for fish or 4 hours for penaeid shrimp (even if they show no sign
    of distress), nor should it exceed 15 minutes for fish eggs.

    Do not apply PARASITE-S to fish ponds, tanks or raceways with water warmer than 27°C
    (80°F) when a heavy bloom of phytoplankton is present, or when the concentration of dissolved
    oxygen is less than 5 mg/L (5 ppm). Do not apply to penaeid shrimp ponds when the
    concentration of the dissolved oxygen is less than 3 to 4 mg/L (ppm). PARASITE-S may kill
    phytoplankton and can cause depletion of dissolved oxygen. If an oxygen depletion occurs,
    add fresh, well-aerated water to dilute the solution and to provide oxygen.

    Because formalin may harm a biofilter, biofilters should be bypassed during treatment, and
    the system should be flushed and replaced with untreated water before reconnecting the
    biofilter.

    Do not use PARASITE-S in a tank, pond or raceway in which methylene blue, or other dyes
    which are absorbed, have been recently used

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  • Environmental Precautions

    Do not discharge the contents of fish treatment tanks into natural streams or ponds without
    thorough dilution (greater than or equal to 10X). Do not discharge the contents of egg treatment
    tanks without a 100X dilution. This will avoid damage to PARASITE-S sensitive phytoplankton,
    zooplankton, and fish populations and avoid depletion of dissolved oxygen.

    Formaldehyde is identified by the U.S. Environmental Protection Agency (EPA) as a toxic pollutant
    and hazardous substance and is required by regulation (40 CFR, Part 122) to be identified
    as a discharge for NPDES permits for aquatic animal production facilities, aquaculture
    projects and other facilities. Formaldehyde is subject to SARA Title Ill, Section 313 reporting.

    Use, storage, and disposal of this product must be handled in accordance with applicable
    local, state and Federal laws.

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  • Storage

    Recommended storage temperature 59°F (15°C). DO NOT EXPOSE TO DIRECT SUNLIGHT.
    Store PARASITE-S indoors away from direct sunlight, heat, spark, and open flame,
    and ventilate storage area. Do not subject PARASITE-S to temperatures below 40°F (4.4°C).

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  • Parasite-S Label
  • INGREDIENTS AND APPEARANCE
    PARASITE-S 
    formaldehyde liquid
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:50378-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Formaldehyde (Formaldehyde) Formaldehyde 370 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    Methyl alcohol 120 g  in 1 L
    Water 510 g  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50378-010-01 208 L in 1 DRUM
    2 NDC:50378-010-05 3.8 L in 1 BOTTLE, PLASTIC
    3 NDC:50378-010-10 19 L in 1 PAIL
    4 NDC:50378-010-99 1000 L in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA140989 07/31/1992
    Labeler - Western Chemical Inc. (085803500)
    Registrant - Western Chemical Inc. (085803500)
    Establishment
    Name Address ID/FEI Business Operations
    Western Chemical Inc. 085803500 label, analysis
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