Label: NEO-OXY 100/100 MR- oxytetracycline hydrochloride and neomycin sulfate powder
- NDC Code(s): 51429-010-03
- Packager: Pharmgate Animal Health
- Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated October 25, 2023
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- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- SPL UNCLASSIFIED SECTION
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VETERINARY INDICATIONS
Mixing and Use Directions Mix Neo-Oxy 100/100 MR® with non-medicated milk replacer to provide the following concentrations: INDICATIONS FOR USE Use Level of Oxytetracycline and Neomycin lbs. of Neo-Oxy 100/100 MR per ton of Type C Medicated Feed* Calves (milk replacer) For Calves (up to 250 lb): For treatment of bacterial enteritis caused by Escherichia coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible by neomycin. Feed continuously for 7-14 days in milk replacer or starter feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. 10 mg/lb body weight/day 20† RESIDUE WARNING: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRERUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL. A MILK DISCARD TIME HAS NOT BEEN ESTABLISHED FOR USE IN LACTATING DAIRY CATTLE. DO NOT USE IN FEMALE DAIRY CATTLE 20 MONTHS OR OLDER, INCLUDING DRY DAIRY COWS. USE IN THESE CATTLE MAY CAUSE DRUG RESIDUES IN MILK AND/OR IN CALVES BORN TO THESE COWS. 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 Calves, Beef Cattle, and Nonlactating Dairy Cattle 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 by neomycin. Feed continuously for 7-14 days in feed or milk replacers. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. 10 mg/lb body weight/day 20† RESIDUE WARNINGS: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRERUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL. A MILK DISCARD TIME HAS NOT BEEN ESTABLISHED FOR USE IN LACTATING DAIRY CATTLE. DO NOT USE IN FEMALE DAIRY CATTLE 20 MONTHS OR OLDER, INCLUDING DRY DAIRY COWS. USE IN THESE CATTLE MAY CAUSE DRUG RESIDUES IN MILK AND/OR IN CALVES BORN TO THESE COWS. 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 or below 25°C (77°F) with excursions permitted to 37°C (98.6°F).
Approved by FDA under NADA # 138-939 - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 22.7 kg Drum Label
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INGREDIENTS AND APPEARANCE
NEO-OXY 100/100 MR
oxytetracycline hydrochloride and neomycin sulfate powderProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:51429-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxytetracycline Hydrochloride (UNII: 4U7K4N52ZM) (Oxytetracycline Anhydrous - UNII:SLF0D9077S) Oxytetracycline Hydrochloride 220 g in 1 kg Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin 220 g in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51429-010-03 22.68 kg in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA138939 12/18/2009 Labeler - Pharmgate Animal Health (833270817) Registrant - Pharmgate Inc. (079628671)