CAUTION: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive (VFD) issued by a licensed veterinarian in the course of the veterinarian's professional practice.

Active Drug Ingredient: Florfenicol 500 g per kg (227.27 g per lb).

Inert Ingredients: Lactose and Povidone.

Description: Each kg of AQUAFLOR® Type A Medicated Article contains 500 grams (1.1 lb) of the antibiotic florfenicol in a palatable base.

Activity: In vitro and in vivo investigations in catfish have established florfenicol's activity against Edwardsiella ictaluri (Table 1).

Table 1: Minimum inhibitory concentration (MIC) of florfenicol against Edwardsiella ictaluri isolated from channel catfish, between 1998-2001.

Indication: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri.

Caution: The effects of florfenicol on reproductive performance have not been determined.

A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for the hematopoietic/lymphopoietic tissues to regenerate was not evaluated.

Precaution: The effects of florfenicol on reproductive performance have not been determined.

Adverse Drug Reactions: A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for the hematopoietic/lymphopoietic tissues to regenerate was not evaluated.

IMPORTANT: Must be thoroughly mixed in feeds before use.

Mixing Instructions: For making AQUAFLOR® -Type C Medicated Feed for catfish: a) AQUAFLOR® is added to other feed ingredients in the mixer prior to extrusion, b) the medicated feed is mixed thoroughly to insure homogeneity, c) the mixture is extruded and pellets are dried, d) the pellets are dry mixed/coated with a predetermined amount of fish or vegetable oil, and e) at the completion of mixing, the product is transferred to a storage tank for packaging or transport.

Feeding Directions: Feed as the sole ration for 10 consecutive days. AQUAFLOR medicated feed should only be administered once disease associated with Edwardsiella ictaluri has been appropriately diagnosed. Feeding fish at a percent of biomass and corresponding florfenicol concentration included in the table above will provide a daily dose rate of 10 mg florfenicol per kg of fish.

Caution: Feed containing AQUAFLOR® (florfenicol) shall not be fed to catfish for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before reinitiating further course of therapy. The expiration date for VFD for AQUAFLOR® (florfenicol) must not exceed 15 days from the date of issuance. VFD for AQUAFLOR® (florfenicol) shall not be refilled.

WARNING: Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators mixing and handling AQUAFLOR® should use protective clothing, gloves, goggles and NIOSH-approved dust mask. Wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists, seek medical attention. Not for human consumption. Keep out of reach of children. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. For more information or to report adverse effects, call 1-800-224-5318. For customer service, call 1-800-521-5767. For a copy of the MSDS sheet, call 1-800-770-8878.

STORAGE CONDITIONS: Store at 2-30°C (36-86°F).
NADA #141-246, Approved by FDA.