Product Label Aquacalm
The contact information listed on the label may not be current. If you have questions about any of the information on the label, please contact AskCVM@fda.hhs.gov.
For immersion use in ornamental finfish only.
Not for use in fish intended for human or animal consumption.
NOT APPROVED BY FDA – Legally marketed as an FDA indexed product under MIF 900-002.
Extra-label use is prohibited.
Note—In order to be legally marketed, an animal drug product intended for a minor species must be Approved, Conditionally Approved, or Indexed by the FDA. THIS PRODUCT IS INDEXED.
It is a violation of Federal law to use this product in a manner other than as directed in the labeling.
As used on this label, the words “ornamental fish” refer to a wide variety of finfish species maintained primarily for their appearance and do not include any fish that are consumed by humans or food-producing animals.
NET CONTENTS: 1, 5, 10 or 50 grams
DESCRIPTION: Each gram of Aquacalm™ powder contains 1 gm of metomidate hydrochloride. Aquacalm™ acts on the central nervous system to induce sedation or anesthesia in fish immersed in water containing the drug.
INDICATION: For the sedation and anesthesia of ornamental finfish.
Aquacalm™ is not for use in fish intended for human or animal consumption. Sedation may be necessary in situations such as strip spawning for hatchery rearing, transporting fish from supplier to wholesaler or retailer, photographing fish as part of a strategic marketing approach, or removal of fish from exhibit tanks prior to cleaning. Anesthesia may be necessary in situations where detailed fish examination or minor surgical procedures are to be conducted.
FOR USE IN ORNAMENTAL FINFISH ONLY.
NOT FOR USE IN FISH INTENDED FOR HUMAN OR ANIMAL CONSUMPTION.
Not for use in humans. Keep out of the reach of children. Use in a well-ventilated area. Wear gloves.
INHALATION: May be harmful. Remove immediately from danger zone and provide fresh air. In case of respiratory problems or respiratory arrest, administer artificial respiration. Keep the affected individual warm and still. Contact emergency medical help.
INGESTION: May be harmful. If the person is conscious, wash out mouth with copious amounts of water. Contact emergency medical help.
EYE CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating eyelids with fingers. Contact emergency medical help.
SKIN CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and wash before re-using. Contact emergency medical help.
OTHER HEALTH INFORMATION: The toxicological properties of metomidate hydrochloride have not been thoroughly investigated. It is thought to act on the central nervous system as an imidazole based non-barbiturate hypnotic.
To obtain a Material Safety Data Sheet, call WESTERN CHEMICAL INC. at (360) 384-5898, or visit www.wchemical.com.
DIRECTIONS FOR USE:
Aquacalm™ is packaged as a dry powder and must be mixed with water to be used. Determine the amount of Aquacalm™ powder needed to achieve the desired concentration for the intended use. Dissolve Aquacalm™ in a known volume of water, mix well, and aerate water during sedation or anesthesia. Lightly sedated fish may lose their ability to maintain upright position or position in a stream flow. Deeply sedated or anesthetized fish will experience total loss of equilibrium. Before beginning sedation or anesthesia, ensure that Aquacalm™-free water is available for recovery. Always test the dosage on a small group of fish first to make sure no unintended or adverse effects occur.
Aquacalm™ has been tested on representative ornamental finfish species, but has not been tested on all fish species. The effect of Aquacalm™ may vary between (and within) species, depending upon age and physical condition of fish, and under different water conditions. Sedate or anesthetize fish in water with temperature and pH close to the temperature and pH of the rearing water.
Caution should be taken when using this product on/for:
- Larval fish species, which may be more sensitive to sedation than older fish of the same species
- Fish species such as knifefish and gouramis
- Any fish species for extended periods (e.g.> 24 hr) used during transportation
Dose for sedation: 0.1 to 1.0 mg/L
Dose for anesthesia: 1.0 to 10.0 mg/L
The dose should be individualized, depending upon the fish species and the degree of anesthesia required. Consideration should be taken when sedating or anesthetizing fish at water temperatures substantially different from the species preferred water temperature or at very low pH.
DURATION OF TREATMENT:
At doses suitable for total loss of equilibrium or anesthesia, do not expose fish for more than 60 min. At doses suitable to sedate fish for transportation, do not expose fish for more than 24 hr. To facilitate recovery upon removal from a solution of Aquacalm™, place fish in well oxygenated, high quality water free of Aquacalm™. Fish should recover in 20 to 90 min.
Use of Aquacalm™ is contraindicated in species of fish that rely upon accessory air breathing organs for oxygen consumption. Sedation or anesthesia of such species may result in unacceptable rates of mortality.
The dose is based on the volume of water in which fish will be placed or held.
For example, if the desired Aquacalm™ concentration is 2.0 mg/L and the tank holding the fish contains 10 L of water, use the following calculation:
2 mg/L X 10L = 20 mg = 0.02 g Aquacalm™
For example, if the desired Aquacalm™ concentration is 2.0 mg/L and the tank holding the fish contains 5 gal of water, use the following calculation (note that the correction factor is used when volume is reported in gallons):
2 mg/L X 5 gal X 0.00378 = 0.038 g Aquacalm™
STORAGE and HANDLING:
Store at 10°C to 30°C (50°F to 86°F) and protect from sunlight or sources of heat.
DISPOSAL: Contact your State Environmental Control Agency, or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance pertaining to disposal of unused product.
QUESTIONS/COMMENTS? For technical assistance, call Western Chemical Inc. at (360) 384-5898. To report an adverse event, call WESTERN CHEMICAL INC. at (360) 384-5898, or FDA at 1-888-FDA-VETS.
WESTERN CHEMICAL INC.
1269 Lattimore Road,
Ferndale WA 98248
Rev : May 19, 2009
NDC Number : 50378-013-01, 50378-013-05, 50378-013-10, 50378-013-50