NEO-TERRAMYCIN 100/100- neomycin-oxytetracycline powder

Neo-Terramycin 100/100 by

Drug Labeling and Warnings

Neo-Terramycin 100/100 by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

(Antibiotic)

Active Drug Ingredients:

Oxytetracycline (from oxytetracycline dihydrate)

equivalent to oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb

Neomycin Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb

CAUTION:

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

CAUTION: For use in manufacturing medicated animal feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

STORE IN A DRY, COOL PLACE

STORE AT OR BELOW 25°C (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)

FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

MIXING AND USE DIRECTIONS

Thoroughly mix the amount of this Type A Medicated Article according to the directions below withat least an equal amount by weight of feed ingredients prior to blending into a complete feed.

Indications for Use	Oxytetracycline and Neomycin Amount	lb. of Neo-Terramycin 100/100 per ton
CHICKENS
Control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline	100-200 g/ton Feed continuously for 7-14 days	1-2
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline	400 g/ton Feed continuously for 7-14 days	4
Reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline	500 g/ton Feed continuously for 5 days	5
WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Low calcium feeds at 500 g/ton, withdraw 3 days before slaughter. Zero-day withdrawal period for lower use levels. In low calcium feeds withdraw 3 days before slaughter. Do not administer to chickens producing eggs for human consumption.
TURKEYS
Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline	100 g/ton Feed continuously for 7-14 days	1
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline	200 g/ton Feed continuously for 7-14 days	2
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline	25 mg/lb of body weight daily Feed continuously for 7-14 days	8.351
WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption.
SWINE
Treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days	52
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	10 mg/lb of body weight daily Feed continuously for not more than 14 days	52
WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage.
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE
For growing cattle (over 400 lb) for reduction of liver condemnation due to liver abscesses	75 mg/head/day Feed continuously	0.753
Prevention and treatment of the early stages of shipping fever complex	0.5-2.0 g/head/day Feed 3-5 days before and after arrival in feedlots	5-203
Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days Treatment should continue 24 to 48 hours beyond remission of disease symptoms.	504
For calves (up to 250 lb) for treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days Treatment should continue 24 to 48 hours beyond remission of disease symptoms.	105
WARNING: A withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. At the 0.5-2.0 g/head/day and 10 mg/lb levels: 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 the 10 mg/lb level, 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.
SHEEP
Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days Treatment should continue 24 to 48 hours beyond remission of disease symptoms.	126
WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage.
1If bird weighs 10 lb, consuming 0.6 lb of complete feed per day 2If pig weighs 100 lb, consuming 4 lb of complete feed per day 3Include in feed supplement based on consumption of 2 lb of supplement per head per day 4If animal weighs 500 lb, consuming 2 lb of supplement per head per day 5If calf weighs 100 lb, consuming 2 lb of complete starter feed per day 6If lamb weighs 60 lb, consuming 1 lb of supplement per head per day

INDICATIONS & USAGE

FOR USE IN ANIMAL FEEDS ONLY

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

SPL UNCLASSIFIED SECTION

NEO-TERRAMYCIN is a registered trademark of Pfizer, Inc

licensed to Phibro Animal Health Corporation for Neomycin-Oxytetracycline

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation or its affiliates.

Phibro Animal Health Corporation, Teaneck, NJ 07666

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS

USE DIRECTIONS AND WARNINGS

Net Weight 50 lb (22.7 kg)

NADA #94-975, Approved by FDA

8851000

101-9069-06

Principal Display Panel

INGREDIENTS AND APPEARANCE

NEO-TERRAMYCIN 100/100 
neomycin-oxytetracycline powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-8851
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE HYDROCHLORIDE	100 g  in 0.45 kg
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	100 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)
RICE BRAN (UNII: R60QEP13IC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-8851-0	22.7 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA094975	03/24/2010

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Health (006989008)