Neo-Terramycin 100/100D: Product Information

NEO-TERRAMYCIN 100/100D- oxytetracycline hydrochloride and neomycin sulfate powder
Phibro Animal Health

(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)

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 DIRECTIONS
USE DIRECTIONS AND WARNINGS NADA #94-975, Approved by FDA 8853000 101-9076-08 Net Weight 50 lb (22.7 kg) FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

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.

202

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.

1 Mixing directions are for example only and are based on mixing 1 lb of dry milk replacer with 1 gallon of water.

2 If calf weighs 100 lb, consuming 1 gallon of milk replacer per day.

FOR USE IN ANIMAL FEEDS ONLY

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

Package/Label Principal Display Panel

Neo-Terramycin 100-100D
(click image for full-size original)
NEO-TERRAMYCIN 100/100D
neomycin-oxytetracycline powder
Product Information
Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:66104-8853
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE ANHYDROUS) OXYTETRACYCLINE HYDROCHLORIDE 100 g in 0.45 kg
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 100 g in 0.45 kg
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
SODIUM ALUMINOSILICATE
SUCROSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66104-8853-0 22.7 kg in 1 BAG None
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)

Revised: 08/2021 Phibro Animal Health

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