PAQFLOR<sup>TM</sup> <br/>(Florfenicol)<br/>Type A Medicated Article
<text/> <effectiveTime value="20250324"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="66104-8101" codeSystem="2.16.840.1.113883.6.69"/> <name>PAQFLOR</name> <formCode code="C42972" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER"/> <asEntityWithGeneric> <genericMedicine> <name>Florfenicol</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="500" unit="g"/> <denominator value="1" unit="kg"/> </quantity> <ingredientSubstance> <code code="9J97307Y1H" codeSystem="2.16.840.1.113883.4.9"/> <name>FLORFENICOL</name> <activeMoiety> <activeMoiety> <code code="9J97307Y1H" codeSystem="2.16.840.1.113883.4.9"/> <name>FLORFENICOL</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="2" unit="kg"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="66104-8101-1" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43200" displayName="POUCH" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> <asContent> <quantity> <numerator value="16" unit="kg"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="66104-8101-2" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43178" displayName="BOX" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> </manufacturedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20241114"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <approval> <id extension="ANADA200803" root="2.16.840.1.113883.3.150"/> <code code="C73583" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANADA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <subjectOf> <characteristic> <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE"/> </characteristic> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="oral"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="L833bf918-1013-4ee6-a4c1-51c5271321fe"> <id root="b8158782-bf1d-42a2-bd7e-0582752df81d"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <title>PAQFLOR<sup>TM</sup> <br/>(Florfenicol)<br/>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
F<content styleCode="bold">or Use in Freshwater-reared Finfish Feeds Only</content> <br/> <br/> <content styleCode="bold">Do Not Feed Undiluted</content> CAUTION: Federal law restricts medicated feed containing this veterinary feed directive
(VFD) drug to use by or on the order of a licensed veterinarian.
<content styleCode="bold">For Use in Freshwater-reared Finfish Feeds Only</content> <br/> <content styleCode="bold">Active Drug Ingredient: Florfenicol 500 g per kg (227.27 g per lb)</content> <br/> <content styleCode="bold">Inert ingredients: Lactose and Povidone.</content> <br/> <content styleCode="bold">Description: Each kg of PAQFLOR<sup>TM</sup> (florfenicol) contains 500 g (1.1 lb) of florfenicol</content> <br/> <content styleCode="bold">in a palatable base.</content> 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.
<text> <paragraph> <content styleCode="bold">Caution:</content> Feed containing PAQFLOR<sup>TM</sup> (florfenicol) shall not be fed to finfish for more<br/>than 10 days. Following administration, fish should be re-evaluated by a licensed veterinarian<br/>before initiating a further course of therapy. The expiration date for VFD for<br/>PAQFLOR<sup>TM</sup> (florfenicol) must not exceed 6 months from the date of issuance. VFD for<br/>PAQFLOR<sup>TM</sup> (florfenicol) shall not be refilled.</paragraph> <paragraph> <br/>Sunburn, skin lesions, and skin sloughing have been reported in salmonids treated with<br/>florfenicol. Not all adverse drug events are reported to FDA CVM. It is not always possible<br/>to reliably estimate the adverse event incidence or to establish a causal relationship<br/>to product exposure using this data alone.</paragraph> <paragraph> <br/>Before using this drug for the first time, you must inform the appropriate National Pollutant<br/>Discharge Elimination System (NPDES) permitting authority of your intentions and of the<br/>following information. Acute and chronic water quality benchmarks for the protection of<br/>freshwater aquatic life have been derived by FDA for florfenicol following EPA guidance for<br/>calculating Tier II water quality criteria for the Great Lakes System (40 CFR 132, App. A).<br/>The acute benchmark value (Secondary Maximum Concentration) is 20.6 mg/L (equivalent<br/>to one-half of the Secondary Acute Value). The chronic benchmark value (Secondary<br/>Continuous Concentration) is 0.23 mg/L (equivalent to the Final Plant Value). The NPDES authority<br/>may require an NPDES permit before you can discharge PAQFLORTM. The water quality<br/>benchmark concentrations are not discharge limits, but may be used by the NPDES authority<br/>to derive such limits for the permit. Additional environmental information on PAQFLORTM<br/>and the benchmark values are available in an environmental assessment posted at<br/>https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/113</paragraph> </text> <effectiveTime value="20250324"/> </section> </component> <component> <section ID="Le2aa1faf-f407-4cd3-ace4-559f214200fa"> <id root="9085b187-1afc-4099-94e3-d519ddc181bf"/> <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/> <title/> <text> <paragraph> <content styleCode="bold">WARNING:</content> Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators<br/>mixing and handling PAQFLOR<sup>TM</sup> (florfenicol) should use protective clothing, gloves, goggles<br/>and NIOSH-approved dust mask. Wash thoroughly with soap and water after handling. If<br/>accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists,<br/>seek medical attention. Not for human consumption. Keep out of reach of children. The<br/>Safety Data Sheet (SDS) contains more detailed occupational safety information.</paragraph> <paragraph> <br/> <content styleCode="bold">CONTACT INFORMATION:</content> To report suspected adverse drug events, for technical assistance or<br/>to obtain a copy of the Safety Data Sheet (SDS), contact Phibro Animal Health Corporation at<br/>888-403-0074 or www.PAHC.com. For additional information about adverse drug experience reporting<br/>for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae<br/> </paragraph> </text> <effectiveTime value="20250324"/> </section> </component> <component> <section ID="L12a37d69-aaa1-42d4-9113-c9156232ab15"> <id root="09e3d898-2d4c-4beb-a9a5-3ded949f9e70"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title/> <text> <paragraph>Approved by FDA under ANADA # 200-803<br/>PAQFLOR is a trademark of Phibro Animal Health Corporation.<br/>Phibro Animal Health Corporation, Teaneck, NJ 07666.</paragraph> <paragraph/> <paragraph>Net Weight: 2kg</paragraph> <paragraph/> <paragraph>101-8404-01B</paragraph> </text> <effectiveTime value="20250324"/> </section> </component> <component> <section ID="Le27a8765-3e5b-40bd-a88c-a90c7e717cb1"> <id root="27ede577-f1da-4d24-9587-ce5c34ea98c9"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <title/> <text> <paragraph> <content styleCode="bold">STORAGE CONDITIONS</content>: Store at temperatures up to 25°C with excursions permitted to 40°C.</paragraph> </text> <effectiveTime value="20250324"/> </section> </component> <component> <section ID="L34a62cd7-10c8-407b-9997-bad2e44d9e6d"> <id root="7e6a8ef6-70ea-4445-b04b-e32a8fcdcfd1"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>Label PAQFLOR Front and Back Label Front Label Back Label