Label: NEO-TERRAMYCIN 100/100- neomycin-oxytetracycline powder
- NDC Code(s): 66104-8851-0
- Packager: Phibro Animal Health
- Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated August 2, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Drug Ingredients:
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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
- FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.
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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
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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)
Approved by FDA under NADA # 094-975
8851000
101-9069-07
- Neo-Terramycin 100-100
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INGREDIENTS AND APPEARANCE
NEO-TERRAMYCIN 100/100
neomycin-oxytetracycline powderProduct 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 ALUMINOSILICATE (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) Establishment Name Address ID/FEI Business Operations Sichuan Long March Pharmaceutical Co. Ltd. 544881741 api manufacture
