PAQFLOR- florfenicol powder

PAQFLOR by

Drug Labeling and Warnings

PAQFLOR by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAQFLORTM (Florfenicol)Type A Medicated Article

Active Drug Ingredient:Florfenicol 500 g per kg (227.27 g per lb)
Description: Each kg of PAQFLORTM (florfenicol) contains 500 g (1.1 lb) of florfenicol in a
palatable base.
Approved by FDA under ANADA # 200-803
PAQFLOR is a trademark of Phibro Animal Health Corporation.
Phibro Animal Health Corporation, Teaneck, NJ 07666.

Lot number:

Expiration:

Net Weight: 2 kg

101-8404-01A

For Use in Freshwater-reared Finfish Feeds Only Do Not Feed Undiluted

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive
(VFD) drug to use by or on the order of a licensed veterinarian.

For Use in Freshwater-reared Finfish Feeds Only Active Drug Ingredient: Florfenicol 500 g per kg (227.27 g per lb) Inert ingredients: Lactose and Povidone. Description: Each kg of PAQFLORTM (florfenicol) contains 500 g (1.1 lb) of florfenicol in a palatable base.

Indications:

Fish Species	Indication	Florefenicol  (mg/kg body weight/day)	Florefenicol (grams/ton)
Freshwater-reared; salmonids	For the control of mortality due; to furunculosis associated with; Aeromonas salmonicida.	10-15	182-2,724
	For the control of mortality due to; coldwater disease associated with; Flavobacterium psychrophilum.
Freshwater-reared; finfish	For the control of mortality due to; columnaris disease associated with; Flavobacterium columnare.	10-15	182-2,724
Catfish	For the control of mortality due; to enteric septicemia of catfish; associated with Edwardsiella ictaluri.	10-15	182-2,724
Freshwater-reared; warmwater finfish	For the control of mortality due to; streptococcal septicemia associated; with Streptococcus iniae.	15	273-2,724

Caution: Not for use in animals intended for breeding purposes. The effects of florfenicol on
reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice
have associated the use of florfenicol with testicular degeneration and atrophy. For catfish, a
dose related decrease in hematopoietic/lymphopoietic tissue may occur. The time required
for the hematopoietic/lymphopoietic tissues to regenerate was not evaluated.

RESIDUE WARNING: Feeds containing PAQFLORTM (florfenicol) must be withdrawn 15 days prior to slaughter.

IMPORTANT: This product has been evaluated in salmonid and catfish feeds and should
be used in feeds nutritionally similar to these evaluated feeds. Refer to the Freedom of
Information Summary for details. Must be thoroughly mixed in feeds or surface-coated
(top-coated) onto the feeds before use.

Mixing Instructions:For incorporation into feed pellets: For making PAQFLORTM (florfenicol) Type C Medicated
Feed: a) PAQFLORTM (florfenicol) is added to other feed ingredients in the mixer prior
to extrusion, b) the ingredients are mixed thoroughly to insure homogeneity, c) the mixture
is steam pelleted or extruded and pellets are dried, d) medicated feed pellets are
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.

For surface-coating (top-coating) onto feed pellets: There are two methods for making
PAQFLORTM (florfenicol) Type C Medicated Feed by top-coating. Method 1:a) add a known
quantity of fish feed into a mixer, b) weigh out PAQFLORTM (florfenicol), c) mix PAQFLORTM
with feed pellets, d) medicated feed pellets are 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. Method 2: a) weigh out fish oil or vegetable oil into
a bucket, b) weigh out PAQFLORTM (florfenicol) and mix thoroughly with the oil in the bucket, 

c) add a known quantity of fish feed into a mixer, d) add the PAQFLORTM (florfenicol) and oil

mixture to the feed in the mixer, slowly, while the mixer is running at low speed, e) at the
completion of mixing, the product is transferred to a storage tank for packaging or transport.

Example of PAQFLORTM (florfenicol) Inclusion Rates for Preparation of Type C Medicated Feed

Feeding Rate	Florfenicol Concentration in Feed		Amount of PAQFLORTM (florfenicol per Ton of Feed)		Biomass of Fish; Medicated per Ton of Feed per 10-day Treatment Period
	Grams/ton		lbs
% Biomass	Dose 10 mg/kg	Dose 15 mg/kg	Dose 10 mg/kg	Dose 15 mg/kg	lbs
0.5	1,816	2,724	8	12	40,000
1	908	1,362	4	6	20,000
2	454	681	2	3	10,000
3	300	450	1.32	1.98	6,666
5	182	273	0.8	1.2	4,000

Feeding Directions: Feed as the sole ration for 10 consecutive days. PAQFLORTM
(florfenicol) medicated feed should only be administered once disease has been appropriately
diagnosed. Feeding fish at a percent of biomass and corresponding florfenicol
concentration included in the table above will deliver the appropriate florfenicol dose.

WARNINGS AND PRECAUTIONS

Caution: Feed containing PAQFLORTM (florfenicol) shall not be fed to finfish for more
than 10 days. Following administration, fish should be re-evaluated by a licensed veterinarian
before initiating a further course of therapy. The expiration date for VFD for
PAQFLORTM (florfenicol) must not exceed 6 months from the date of issuance. VFD for
PAQFLORTM (florfenicol) shall not be refilled.

Sunburn, skin lesions, and skin sloughing have been reported in salmonids treated with
florfenicol. Not all adverse drug events are reported to FDA CVM. It is not always possible
to reliably estimate the adverse event incidence or to establish a causal relationship
to product exposure using this data alone.

Before using this drug for the first time, you must inform the appropriate National Pollutant
Discharge Elimination System (NPDES) permitting authority of your intentions and of the
following information. Acute and chronic water quality benchmarks for the protection of
freshwater aquatic life have been derived by FDA for florfenicol following EPA guidance for
calculating Tier II water quality criteria for the Great Lakes System (40 CFR 132, App. A).
The acute benchmark value (Secondary Maximum Concentration) is 20.6 mg/L (equivalent
to one-half of the Secondary Acute Value). The chronic benchmark value (Secondary
Continuous Concentration) is 0.23 mg/L (equivalent to the Final Plant Value). The NPDES authority
may require an NPDES permit before you can discharge PAQFLORTM. The water quality
benchmark concentrations are not discharge limits, but may be used by the NPDES authority
to derive such limits for the permit. Additional environmental information on PAQFLORTM
and the benchmark values are available in an environmental assessment posted at
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/113

WARNINGS

WARNING: Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators
mixing and handling PAQFLORTM (florfenicol) 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
Safety Data Sheet (SDS) contains more detailed occupational safety information.

CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or
to obtain a copy of the Safety Data Sheet (SDS), contact Phibro Animal Health Corporation at
888-403-0074 or www.PAHC.com. For additional information about adverse drug experience reporting
for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

SPL UNCLASSIFIED SECTION

Approved by FDA under ANADA # 200-803
PAQFLOR is a trademark of Phibro Animal Health Corporation.
Phibro Animal Health Corporation, Teaneck, NJ 07666.

Net Weight: 2kg

101-8404-01B

STORAGE AND HANDLING

STORAGE CONDITIONS: Store at temperatures up to 25°C with excursions permitted to 40°C.

Label

PAQFLOR Front and Back Label

INGREDIENTS AND APPEARANCE

PAQFLOR 
florfenicol powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-8101
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLORFENICOL (UNII: 9J97307Y1H) (FLORFENICOL - UNII:9J97307Y1H)	FLORFENICOL	500 g  in 1 kg

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-8101-1	2 kg in 1 POUCH
2	NDC: 66104-8101-2	16 kg in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200803	11/14/2024

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Health (006989008)