Label: TETROXY 25- oxytetracycline hcl powder

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated December 1, 2022

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  • DESCRIPTION

    Tetroxy® 25

    (oxytetracycline HCl)

    Soluble Powder

    CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

    A broad spectrum ANTOBIOTIC

    FOR CONTROL AND TREATMENT OF SPECIFIC DISEASES

    IN POULTRY, CATTLE, SHEEP, SWINE AND HONEY BEES.

    This packet contains 10 grams of oxytetracycline hydrochloride

    For oral use in poultry, cattle, sheep, swine and honey bees.

    FOR USE IN DRINKING WATER ONLY

    NOT FOR USE IN LIQUID FEED SUPPLEMENTS

    NOT FOR USE IN HUMANS

    KEEP OUT OF REACH OF CHILDREN


    Restricted Drug (California) - Use Only as Directed

    ANADA 200-146, Approved by FDA

  • INDICATIONS & USAGE

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  • CONTRAINDICATIONS

    CONTRAINDICATION: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells.

  • PRECAUTIONS

    PRECAUTIONS: Use as sole source of oxytetracycline. Prepare fresh solutions every 24 hours.

    Special Note: The concentration of drug required in medicated water must be adequate to compensate for variation in the age of the animal, feedconsumption rate and the environmental temperature and humidity, each of which affects water consumption.

  • RESIDUE WARNING

    RESIDUE WARNING: Do not administer turkeys, cattle or sheep within 5 days of slaughter. Zero-day slaughter withdrawal in swine.  Do not administer to chickens or turkeys producing eggs for human consumption. Do not administer this product with milk replacers. Adminster 1 hour before or 2 hours after feeding milk or milk replacers. A milk discard period has not been estblished for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. For honey bees, the drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow.

  • STORAGE AND HANDLING

    STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    TETROXY 25 
    oxytetracycline hcl powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-5025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE10 g  in 181.5 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-5025-1181.5 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20014609/28/2017
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Liberty Pharmaceutical Co., Ltd.529588375api manufacture