Label: CHLORONEX- chlortetracycline hydrochloride powder, for solution

  • NDC Code(s): 23243-4500-1, 23243-4500-2
  • Packager: Huvepharma, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 11, 2019

If you are a consumer or patient please visit this version.

  • 6.4 oz. Front Panel

    Chloronex®
    (Chlortetracycline hydrochloride)
    Soluble Powder

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

    Chlortetracycline HCl, 64 g/lb

    Antibiotic

    For Animal Use in Drinking Water
    Net Wt: 6.4 oz (181.4 g)
    NADA 065-440, Approved by FDA

    Huvepharma®

    1114143009
    Rev. 12-2015

    Not for Human Use. Restricted Drug (California)-Use Only as Directed

    Chloronex is a registered trademark of Huvepharma EOOD
    Manufactured for: Huvepharma, Inc.

    525 Westpark Dr., Suite 230, Peachtree City, GA 30269 U.S.A.

    Lot No. & Exp. Date

  • Indications and Directions for Use

    This 6.4 oz packet contains 25.6 g chlortetracycline HCl (64 g/lb) and will make the resulting concentrations:

    Gallons of water                              256         128            64         25.6

    Chlortetracycline HCl per gallon         100 mg   200 mg       400 mg  1000 mg

    Growing Turkeys

    Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

    Dose

    400 mg/gal (4 packets/256 gallons). This is equivalent to 1/2 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Growing Turkeys

    Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.

    Dose

    25 mg/lb body weight (1 packet for every 1,024 lbs of turkeys). 1/8 oz treats a 20 lb turkey for one day. Mix until dissolved. Administer in the  total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Swine

    Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline.

    Dose - 10 mg/pound body weight daily

    (10 packets/256 gallons will treate 256 100-lb pigs per day). 1/4 oz of powder will treat a 100 lb pig for one day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period. Administer for 3 to 5 days.

    Calves

    Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline.

    Dose - 10 mg/pound body weight daily

    Use 1/2 oz of poweder for each 200 lbs of calf weight, per day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24 hour period, or as a drench in divided doses. Administer 3 to 5 days.

    Chickens

    Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

    Dose

    200-400 mg/gal (2-4 packets/256 gallons). This is equivalent to 1/4-1/2 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the inidcated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Chickens

    Control of Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasm gallisepticum and Escherichia coli susceptible to chlortetracycline.

    Dose

    400-800 mg/gal (4-8 packets/256 gallons). This is equivalent to 1/2 - 1 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Chickens

    Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

    Dose

    1000 mg/gal (10 packets/256 gallons). This is equivalent to 1/4 oz of powder per 1 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Medicate chickens and turkeys continuously at the first clinical signes of disease and continue for 7 to 14 consecutive days. The dosage ranges permitted provide for different levels based on the severity of the infection. If improvement is not noted in 24-48 hours, consult your veterinarian.

    General Information on Dosage:

    Dosages in terms of packets per 256 gallons are based on stated dosages per unit of body weight and average water consumption of the species. Weather conditions, ambient temperature, humidity, age, class of livestock and other factors may affect consumption and, except where calves are drenched, the unit dosage should be used as a guide to effective use in drinking water. Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.

  • Residue Warnings

    Do not administer to chickens, growing turkeys, swine, and cattle within 24 hours of slaughter. Do not use in lactating dairy cattle and laying chickens. A withdrawal period has not been established in preruminating calves. Do not use in calves to processed for veal.

  • Precautions

    Use as the sole source of chlortetracycline. Prepare fresh solutions daily. When used in plastic or stainless steel waterers or automatic waterers, prepare fresh solutions every 24 hours. This product has not been demonstrated to provide adequate stability in galvanized waterers. Stability loss may reduce effectiveness of the product. Do not administer in milk or milk replacers. When feeding milk or milk replacers, administer one hour before or two hours after feeding is recommended.

  • Storage and Handling

    Store at or below 25°C (77°F)

  • 25.6 oz. Front Panel

    Chloronex®
    (Chlortetracycline hydrochloride)
    Soluble Powder

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

    Chlortetracycline HCl, 64 g/lb

    Antibiotic

    For Animal Use in Drinking Water
    Net Wt: 6.4 oz (181.4 g)
    NADA 065-440, Approved by FDA

    Huvepharma®

    1114143009
    Rev. 12-2015

    Not for Human Use. Restricted Drug (California)-Use Only as Directed

    Chloronex is a registered trademark of Huvepharma EOOD
    Manufactured for: Huvepharma, Inc.

    525 Westpark Dr., Suite 230, Peachtree City, GA 30269 U.S.A.

    Lot No. & Exp. Date

  • Indications and Directions for Use

    This 25.6 oz packet contains 102.4 g chlortetracycline HCl (64 g/lb) and will make the resulting concentrations:

    Gallons of water                              1024       512        256       128        102.4

    Chlortetracycline HCl per gallon         100 mg   200 mg   400 mg  800 mg  1000 mg 

    Growing Turkeys

    Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

    Dose

    400 mg/gal (2 packets/512 gallons). This is equivalent to 1/2 oz of powder per 5 gallons of water. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Growing Turkeys

    Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.

    Dose

    25 mg/lb body weight/day (1 packet for every 4,096 lbs of turkeys). 1/8 oz treats a 20 lb turkey for one day. Mix until dissolved. Administer in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Swine

    Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline.

    Dose - 10 mg/pound body weight daily

    (5 packets/512 gallons will treat 512 100-lb pigs per day). 1/4 oz of powder will treat a 100 lb pig for one day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period. Administer for 3 to 5 days.

    Calves

    Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline.

    Dose - 10 mg/pound body weight daily

    Use 1/2 oz of powder for each 200 lbs of calf weight, per day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period or as a drench in divided doses. Administer for 3 to 5 days.

    Water Medicators: Dissolve the contents of one 25.6 oz packet in 100 oz of fresh water to prepare a stock solution, that when metered at the rate of 1 oz per gallon of drinking water, will deliver 1000 mg of chlortetracycline HCl per gallon. At this rate, a gallon of drinking water will treat a 100 lb pig or 100 lb calf at the rate of 10 mg per lb of body weight for one day. Adjust if needed based on actual water intake to acheive 10 mg per lb of body weight.

    Chickens

    Contol of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

    Dose

    200-400 mg/gal (1-2 packets/512 gallons). This is equivalent to 1/4-1/2 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Chickens

    Control of Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasm gallisepticum and Escherichia coli susceptible to chlortetracycline.

    Dose

    400-800 mg/gal (2-4 packets/512 gallons). This is equivalent to 1/2 - 1 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Chickens

    Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

    Dose

    1000 mg/gal (5 packets/512 gallons). This is equivalent to 1/4 oz of powder per 1 gallon of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full, 24-hour period. Administer 7 to 14 days.

    Medicate chickens and turkeys continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days. The dosage ranges permitted provide for different levels based on the severity of the infection. If improvement is not noted in 24-48 hours, consult your veterinarian.

    General Information on Dosage:

    Dosages in terms of packets per 256 gallons are based on stated dosages per unit of body weight and average water consumption of the species. Weather conditions, ambient temperature, humidity, age, class of livestock and other factors may affect consumption and, except where calves are drenched, the unit dosage should be used as a guide to effective use in drinking water. Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.

  • Residue Warnings

    Do not administer to chickens, growing turkeys, swine, and cattle within 24 hours of slaughter. Do not use in lactating dairy cattle and laying chickens. A withdrawal period has not been established in preruminating calves. Do not use in calves to processed for veal.

  • Precautions:

    Use as the sole source of chlortetracycline. Prepare fresh solutions daily. When used in plastic or stainless steel waterers or automatic waterers, prepare fresh solutions every 24 hours. This product has not been demonstrated to provide adequate stability in galvanized waterers. Stability loss may reduce effectiveness of the product. Do not administer in milk or milk replacers. When feeding milk or milk replacers, administer one hour before or two hours after feeding is recommended.

  • Storage and Handling

    Store at or below 25°C (77°F)

  • 6.4 oz Packet Label

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  • 25.6 oz Packet Label

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  • INGREDIENTS AND APPEARANCE
    CHLORONEX 
    chlortetracycline hydrochloride powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:23243-4500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORTETRACYCLINE HYDROCHLORIDE (UNII: O1GX33ON8R) (CHLORTETRACYCLINE - UNII:WCK1KIQ23Q) CHLORTETRACYCLINE HYDROCHLORIDE64 g  in 0.45 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-4500-10.181 kg in 1 POUCH
    2NDC:23243-4500-20.726 kg in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA06544010/30/2015
    Labeler - Huvepharma, Inc. (619153559)
    Registrant - Huvepharma EOOD (552691651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc. - St. Louis883128204manufacture, analysis, pack, label, medicated animal feed manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc - Longmont080346321label, manufacture, pack