Label: NEO-TERRAMYCIN 100/100D- neomycin-oxytetracycline powder
- NDC Code(s): 66104-8853-0
- 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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- (Antibiotic)
- 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.
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STORE IN A DRY, COOL PLACE
STORE AT OR BELOW 25°C (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)
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 of its affiliates.
Phibro Animal Health Corporation, Teaneck, NJ 07666
- SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONSUSE DIRECTIONS AND WARNINGSApproved by FDA under NADA # 094-9758853000101-9076-08Net Weight 50 lb (22.7 kg)FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.
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MIXING AND USE DIRECTIONS
Mix Neo-Terramycin 100/100D with nonmedicated milk replacer to provide the following drug concentrations:
Indications for Use
Oxytetracycline and
Neomycin Amount
lb. of
Neo-Terramycin 100/100D per ton1
CALVES (milk replacer)
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.
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CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE
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.
202
WARNING: A withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. 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.
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.
1Mixing directions are for example only and are based on mixing 1 lb of dry milk replacer with 1 gallon of water.
2If calf weighs 100 lb, consuming 1 gallon of milk replacer per day.
- INDICATIONS & USAGE
- Neo-Terramycin 100/100D
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INGREDIENTS AND APPEARANCE
NEO-TERRAMYCIN 100/100D
neomycin-oxytetracycline powderProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:66104-8853 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) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66104-8853-0 22.7 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA094975 07/08/2009 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
