NEO-OXY 50/50- oxytetracycline and neomycin sulfate powder

Neo-Oxy 50/50 by

Drug Labeling and Warnings

Neo-Oxy 50/50 by is a Animal medication manufactured, distributed, or labeled by Pharmgate Animal Health, Pharmgate LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Oxytetracycline, Neomycin
Type A Medicated Article

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 Use	Use Level of Oxytetracycline and Neomycin Sulfate	lbs. of Neo-Oxy 50/50 per ton of Type C Medicated Feed
* If bird weighs 10 lb, consuming 0.6 lb of complete feed per day † If lamb weighs 60 lb, consuming 1 lb of supplement per head per day ‡ If pig weighs 100 lb, consuming 4 lb of complete feed per day § If calf weighs 100 lb, consuming 2 lb of complete starter feed per day ¶ Include in feed supplement based on consumption of 2 lb of supplement per head per day # If animal weighs 500 lb, consuming 2 lb of supplement per head per day
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/ton	2.0-4.0
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/ton	8.0
For reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline. Feed continuously for 5 days.	500g/ton	10.0
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/ton	2.0
For control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline. Feed continuously for 7-14 days.	200g/ton	4.0
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*
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†
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‡
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§
For Growing Cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses. Feed continuously.	75mg/head/day	1.5¶
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/day	10-40¶
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#
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 25°C (77°F) with excursions permitted to 37°C (98.6°F); NADA 138-939 Approved by FDA

SPL UNCLASSIFIED SECTION

Net wt. 50 LB (22.68 Kg)

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

Take Time

Observe 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

INGREDIENTS AND APPEARANCE

NEO-OXY 50/50 
oxytetracycline and neomycin sulfate powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 51429-055
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxytetracycline (UNII: X20I9EN955) (Oxytetracycline Anhydrous - UNII:SLF0D9077S)	Oxytetracycline	110 g  in 1 kg
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	110 g  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
Calcium Carbonate (UNII: H0G9379FGK)
Mineral Oil (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51429-055-03	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA138939	12/01/2009

Labeler - Pharmgate Animal Health (833270817)

Registrant - Pharmgate LLC (079628671)