Label: AQUACALM- metomidate powder

  • NDC Code(s): 50378-013-01, 50378-013-02, 50378-013-05, 50378-013-06, view more
    50378-013-10, 50378-013-11, 50378-013-50
  • Packager: Western Chemical Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Legally Marketed Unapproved New Animal Drugs for Minor Species

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 September 19, 2012

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    NET CONTENTS: 1, 5, 10 or 50 grams

    DESCRIPTION:  Each gram of AquacalmTM powder contains 1 gm of metomidate hydrochloride. AquacalmTM acts on the central nervous system to induce sedation or anesthesia in fish immersed in water containing the drug.

  • INDICATIONS & USAGE

    INDICATION:  For the sedation and anesthesia of ornamental finfish. AquacalmTM 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.

  • WARNINGS AND PRECAUTIONS

    CAUTION:
    FOR USE IN ORNAMANTAL FINFISH ONLY.
    NOT FOR USE IN FISH INTENDED FOR HUMAN OR ANIMAL CONSUMPTION
    .

    WARNING:
    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

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE:
    AquacalmTM is packaged as a dry powder and must be mixed with water to be used. Determine the amount of AquacalmTM powder needed to achieve the desired concentration for the intended use. Dissolve AquacalmTM 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 AquacalmTM-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.

    SPECIES:
    AquacalmTM has been tested on representative ornamental finfish species, but has not been tested on all fish species. The effect of AquacalmTM 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:
    1. Larval fish species, which may be more sensitive to sedation than older fish of the same species
    2. Fish species such as knifefish and gouramis
    3. Any fish species for extended periods (e.g.> 24 hr) used during transportation

    DOSAGE:
    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 AquacalmTM, place fish in well oxygenated, high quality water free of AquacalmTM. Fish should recover in 20 to 90 min.

    CONTRAINDICATIONS:
    Use of AquacalmTM 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.

    DOSE CALCULATION:

    The dose is based on the volume of water in which fish will be placed or held.
    For example, if the desired AquacalmTM 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 AquacalmTM
    For example, if the desired AquacalmTM 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 AquacalmTM
  • STORAGE AND HANDLING

    STORAGE and HANDLING:
    Store at 10°C to 30°C (50°F to 86°F) and protect from sunlight and 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.
  • PRINCIPAL DISPLAY PANEL


    Aquacalm 1, 5 and 10 gram label


    Aquacalm box label


    Aquacalm 50 gram label

  • INGREDIENTS AND APPEARANCE
    AQUACALM 
    metomidate powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50378-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    metomidate (UNII: Z18ZYL8Y51) (metomidate - UNII:Z18ZYL8Y51) metomidate1000 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50378-013-021 in 1 CARTON
    1NDC:50378-013-011 g in 1 BOTTLE, PLASTIC
    2NDC:50378-013-061 in 1 CARTON
    2NDC:50378-013-055 g in 1 BOTTLE, PLASTIC
    3NDC:50378-013-111 in 1 CARTON
    3NDC:50378-013-1010 g in 1 BOTTLE, PLASTIC
    4NDC:50378-013-5050 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Legally Marketed Unapproved New Animal Drugs for Minor SpeciesMIF90000206/15/2009
    Labeler - Western Chemical Inc. (085803500)
    Registrant - Western Chemical Inc. (085803500)