Animal NDC 50378-013-06 Aquacalm

Field Name	Field Value
Animal NDC Code	50378-013-06
Proprietary Name	Aquacalm What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Metomidate What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name	Western Chemical Inc.
Product Type	Otc Animal Drug
Active Ingredient(s)	Metomidate
Marketing Category	LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number	MIF900002 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents

• Dosage & Administration
• Storage And Handling
• Package Label.Principal Display Panel

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 species2. Fish species such as knifefish and gouramis3. Any fish species for extended periods (e.g.> 24 hr) used during transportationDOSAGE:Dose for sedation: 0.1 to 1.0 mg/LDose for anesthesia: 1.0 to 10.0 mg/LThe 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 AquacalmTMFor 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.

Package Label.Principal Display Panel