Animal NDC 51429-055-03 Neo-oxy 50/50

Oxytetracycline And Neomycin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 51429-055-03
Proprietary Name Neo-oxy 50/50 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 And Neomycin Sulfate 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
    FOR USE IN THE MANUFACTURE OF MEDICATED ANIMAL FEEDS
Active Ingredient(s)
  • Oxytetracycline
  • Neomycin Sulfate
Inactive Ingredient(s)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
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 NADA138939 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.

Neo-oxy 50/50 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



Description



Active Drug Ingredients: Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50 grams/lb. Oxytetracycline HCl. Neomycin sulfate 50 grams/lb.

Ingredients: Calcium carbonate, Roughage products, Oxytetracycline, Neomycin sulfate and Mineral oil.


Indications & Usage



FOR USE IN THE MANUFACTURE OF MEDICATED ANIMAL FEEDS


Precautions



CAUTION: For Use in Dry Feeds ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS


Directions For Use



Indications For UseUse Level of Oxytetracycline and Neomycin Sulfatelbs. of Neo-Oxy 50/50® per ton of Type C Medicated Feed
Chickens
For control of infectious synovitis caused by Mycoplasma synoviae, control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline. Feed continuously for 7-14 days.100-200g/ton2.0-4.0
For 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.400g/ton8.0
For reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline. Feed continuously for 5 days.500g/ton10.0
RESIDUE WARNING: AT 500 G/TON LEVEL, WITHDRAW 24 HOURS BEFORE SLAUGHTER. ZERO-DAY WITHDRAWAL PERIOD FOR LOWER USE LEVELS. IN LOW CALCIUM FEEDS WITHDRAW 3 DAYS BEFORE SLAUGHTER. DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION.
Turkeys
For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline. Feed continuously for 7-14 days.100g/ton2.0
For control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline. Feed continuously for 7-14 days.200g/ton4.0
For 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
16.7

If bird weighs 10 lb, consuming 0.6 lb of complete feed per day

RESIDUE WARNING: AT 200 G/TON USE LEVEL OR HIGHER, WITHDRAW 5 DAYS BEFORE SLAUGHTER. ZERO-DAY WITHDRAWAL PERIOD AT 100G/TON USE LEVELS. DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION.
Sheep
For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin. Feed continuously for 7-14 days. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.10 mg/lb body
weight/day
24

If lamb weighs 60 lb, consuming 1 lb of supplement per head per day

RESIDUE WARNING: WITHDRAW 5 DAYS BEFORE SLAUGHTER AT 10 MG/LB DOSAGE.
Swine
For Swine: For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin. Feed continuously for 7-14 days.10 mg/lb body
weight/day
10

If pig weighs 100 lb, consuming 4 lb of complete feed per day

For Breeding Swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. Feed continuously for not more than 14 days.10 mg/lb body
weight/day
10
RESIDUE WARNING: WITHDRAW 5 DAYS BEFORE SLAUGHTER AT 10 MG/LB DOSAGE.
Calves, Beef Cattle, and Nonlactating Dairy Cattle
For Calves (up to 250 lbs.): For treatment of bacterial enteritis caused by Escherichia coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin. Feed continuously for 7 to 14 days in starter feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.10 mg/lb body
weight/day
20

If calf weighs 100 lb, consuming 2 lb of complete starter feed per day

For Growing Cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses. Feed continuously.75mg/head/day1.5

Include in feed supplement based on consumption of 2 lb of supplement per head per day

For prevention and treatment of the early stages of shipping fever complex. Feed 3-5 days before and after arrival in feedlots.0.5-2.0g/head/day10-40
For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin. Feed continuously for 7-14 days in feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.10 mg/lb body
weight/day
100

If animal weighs 500 lb, consuming 2 lb of supplement per head per day

RESIDUE WARNING: AT 0.5-2.0 G/HEAD/DAY AND 10 MG/LB DOSAGES: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRE-RUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL. AT 0.5-2.0 G/HEAD/DAY AND 10 MG/LB DOSAGES: A MILK DISCARD TIME HAS NOT BEEN ESTABLISHED FOR USE IN LACTATING DAIRY CATTLE. DO NOT USE IN FEMALE DAIRY CATTLE 20 MONTHS OF AGE OR OLDER. AT 10 MG/LB DOSAGE, WITHDRAW 5 DAYS BEFORE SLAUGHTER. USE OF MORE THAN ONE PRODUCT CONTAINING NEOMYCIN OR FAILURE TO FOLLOW WITHDRAWAL TIMES MAY RESULT IN ILLEGAL DRUG RESIDUES.
Store at or below 25°C (77°F) with excursions permitted to 37°C (98.6°F)
Approved by FDA under NADA # 138-939

Other



Net wt. 50 LB (22.68 Kg)

Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, NE 68144

Take TimeObserve Directions

Principal Display Panel - 22.68 Kg Bag Label



Neo-Oxy 50/50®

Oxytetracycline
Neomycin
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.