Animal NDC 51429-103-02 Pennox 100 Hi-flo
Oxytetracycline
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 51429-103-02 |
| Proprietary Name | Pennox 100 Hi-flo 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 | Oxytetracycline 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 | Pharmgate Animal Health |
| Product Type | Vfd Type A Medicated Article Animal Drug |
| Usage Information |
|
| Active Ingredient(s) |
|
| Inactive Ingredient(s) |
|
| Marketing Category | NADA - NEW ANIMAL DRUG APPLICATION 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 | NADA138938 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. |
Pennox 100 Hi-flo Images
Pennox 100 Hi-flo Animal Product Labeling Information
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
Other
Oxytetracyline
Type A Medicated Article
Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, NE 68144
Take TimeObserve Directions
Description
Active Drug Ingredients: Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 100 grams Oxytetracycline Hydrochloride/lb.
Ingredients: Oxytetracycline, Calcium Carbonate, Roughage Products and Mineral Oil.
Food Safety Warning
For Use in the Manufacture of Medicated Feeds. Do Not Feed Undiluted.
CAUTION: For use in Dry Feeds ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS
Directions For Use
| INDICATIONS FOR USE | Use Level of Oxytetracycline | lbs. of Pennox 100 Hi-Flo® per ton |
|---|---|---|
| Approved by FDA under NADA # 138-938 Pennox 100 Hi-Flo® is the registered trademark of Pharmgate Inc. | ||
| Chickens | ||
| For Chickens: Control of infectious synovitis caused by Mycoplasma synoviae, control of fowl cholera caused by Pasteurella multocida sensitive to oxytetracycline. (Feed continuously for 7 - 14 days) | 100-200 g/ton | 1.0 – 2.0 |
| For Chickens: Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline. (Feed continuously for 7 - 14 days). | 400 g/ton | 4.0 |
| For Broiler Chickens: Reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline (Feed continuously for 5 days). | 500 g/ton | 5.0 |
| Withdrawal Periods and Residue Warnings: Do not feed to chickens producing eggs for human consumption. Do not use in low calcium feed containing less than 0.55% dietary calcium. Use in such feeds may result in violative residues. 24 hour withdrawal period at 500 g/ton use levels. No withdrawal period is required when used according to labeling at 100 – 200 g/ton and 400 g/ton use levels. | ||
| Turkeys | ||
| For Turkeys: Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline. (Feed continuously for 7 - 14 days). | 100 g/ton | 1.0 |
| For Turkeys: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline (Feed continuously for 7 - 14 days) | 200g/ton | 2.0 |
| For Turkeys: Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline. (Feed continuously for 7 - 14 days) | 25 mg/lb. body weight/day | |
| Withdrawal Periods and Residue Warnings: Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period. | ||
| Swine | ||
| For Swine: Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. (Feed continuously for 7-14 days.) | Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb. body weight/ day | |
| For Breeding Swine: Control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. (Feed continuously for 14 days) | Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb. body weight/ day | |
| Withdrawal Periods: Zero-day withdrawal period. | ||
| Calves, Beef Cattle, and Nonlactating Dairy Cattle | ||
| For Growing cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses. (Use continuously) | 75 mg/head/day | |
| For Cattle: For the prevention and treatment of the early stages of the shipping fever complex. (Feed 3-5 days before and after arrival in feedlots.) | 0.5-2.0g/head/day | |
| For Calves, Beef Cattle, and Nonlactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline. (Feed continuously for 7-14 days) | 10 mg/lb. body weight/day | |
| Withdrawal Periods and Residue Warnings: This drug product is not approved for use in female cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residue in milk and/or in calves born to these cows. 5-day withdrawal period at 10 mg/lb. body weight/day use level. No withdrawal period is required when used according to labeling at 75 mg/head/day and 0.5-2.0g/head/day use levels. | ||
| Sheep | ||
| For Sheep: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. (Feed continuously for 7-14 days) | 10 mg/lb. body weight/day | |
| Withdrawal Periods: 5-day withdrawal period. | ||
| Honey Bees | ||
| Control of American Foulbrood caused by Paenibacillus larvae and European Foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline. | 200 mg/oz (Dusting) 200 mg/5 lb (Syrup) 800 mg/patty (Extender Patty) | |
| See Mixing, Preparation and Feeding Directions below. | ||
| Mixing Directions for Honey Bees To manufacture a Type B medicated feed containing 20g/lb of oxytetracycline hydrochloride activity, mix 5 lb of Pennox 100 Hi-Flo with 20 lb of powdered sugar (for a total of 25 lb.) To manufacture a Type C medicated feed containing 200 mg of oxytetracycline hydrochloride activity per oz (dusting Type C medicated feed), mix 7 lb of Pennox 100 Hi-Flo with 211 lb of powdered sugar (for a total of 218 lb). The resulting Type C medicated feed is fed as-is for dusting, or is used to prepare syrup and extender patty feeds. Feeding Directions for Dusting: Dusting: Apply 1 oz (200 mg oxytetracycline) of dusting Type C medicated feed per colony every 4 to 5 days for a total of 3 applications. Apply the dust on the outer parts or ends of the frames. Caution: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells. Preparation and Feeding Directions for Syrup: Preparation: First dissolve 1 oz (200 mg oxytetracycline) of the dusting Type C medicated feed in a small quantity of water, then mix into 5 lb of 1:1 sugar syrup (equal parts sugar and water, w/w). Feeding: Feed 5 lb of syrup (200 mg oxytetracycline) per colony every 4 to 5 days for a total of 3 applications. Bulk feed the syrup using feeder pails, or division board feeders, or by filling the combs. Prepare fresh syrup for each application. Preparation and Feeding Directions for Extender Patty: Preparation: Make one patty by mixing 4 oz (800 mg oxytetracycline) of the dusting Type C medicated feed with 5.8 oz (165 g) of vegetable shortening and 11.6 oz (330 g) of sugar. Feeding: Place one patty per colony on the top bars of the brood nest frames in a single application. Warnings: Withdrawal Periods and Residue Warnings: Remove at least 6 weeks prior to main honey flow. Type C medicated feeds should be fed in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Honey stored during medication periods in combs for surplus honey should be removed following final mediation of the bee colony and must not be used for human food. Waring: Do not use in a manner contrary to state apiary laws and regulations. Each state has specific regulations relative to disease control and medication. Contact the appropriate official or state departments of agriculture for specific inter- and intrastate laws and regulations. | ||
Principal Display Panel - 22.68 Kg Bag
Pennox 100 Hi-Flo®
Oxytetracycline
Type A Medicated Article
CAUTION: Federal law restricts medicated feed containing this
veterinary feed directive (VFD) drug to use by or on the order of a
licensed veterinarian.
See mixing directions, claims, cautions and warnings on back.
Restricted Drug (California) - Use Only as Directed.
Not For Human Use.
Net wt. 50 LB (22.68 Kg)
Pharmgate
ANIMAL HEALTH
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.