Label: GENTAMICIN PIGLET - gentamicin sulfate injection

  • NDC Code(s): 58005-663-04, 58005-663-05, 58005-663-06
  • Packager: Sparhawk Laboratories, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/13

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  • SPL UNCLASSIFIED SECTION

    Piglet Injection Veterinary

    Antibacterial

    For Piglets Up to 3 days of age

    For intramuscular use only.

    ANADA#: 200-394 Approved by F.D.A
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  • DESCRIPTION

    Gentamicin Piglet Injection is a sterile preparation for intramuscular administration in piglets up to 3 days of age. Each milliliter contains gentamicin sulfate, USP equivalent to 5 mg gentamicin base, 2 mg sodium bisulfite, 0.1 mg edetate disodium, 7.46 mg sodium acetate, 3 mg glacial acetic acid; 1.3 mg methylparaben and 0.2 mg propylparaben as preservatives, water for injection q.s.

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  • WARNING

    For use in piglets up to 3 days of age only.

    Piglets injected with Gentamicin Piglet Injection must not be slaughtered for food for at least forty (40) days following treatment. Use of more than the recommended dose will result in gentamicin tissue residues beyond forty (40) days.

    Restricted Drug (California)--use only as directed.

    Read accompanying directions carefully.

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  • INDICATIONS

    Gentamicin Piglet Injection is recommended for the treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin.

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  • DOSAGE AND ADMINISTRATION

    The recommended dose is 1 mL (5 mg) administered intramuscularly. Gentamicin Piglet Injection is not to be used more than once in each piglet. If piglets do not respond to treatment with Gentamicin Piglet Injection, diagnosis should be reevaluated. Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use. Prior to injection, disinfect the injection site and top the vial with a suitable disinfectant, such as 70% alcohol. Use all precautions to prevent contamination of vial contents.

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  • CONTRAINDICATIONS

    There are no known contraindications to this drug when used as directed.

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  • PRECAUTIONS

    Store between 2o and 30oC (36o and 86oF)

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  • CHEMISTRY

    Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin Sulfate, USP is a mixture of sulfate salts of the antibiotics produced in the fermentation. The salts are weakly acidic and freely soluble in water. Gentamicin sulfate, USP is stable in solution for the period of time indicated on the labels by the expiration date.

    Gentamicin sulfate, USP contains not less than 500 micrograms of gentamicin base per milligram.

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  • HOW SUPPLIED

    Enter section text here

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  • STORAGE AND HANDLING

    Store between 2o and 30oC (36oand 86oF)

    Protect from freezing.

    For intramuscular use only.

    TAKE TIME OBSERVE LABEL DIRECTIONS

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  • PRINCIPAL DISPLAY PANEL

    Manufactured by
    Sparhawk Laboratories, Inc.
    Lenexa, KS 66215

    G-6639-04                       Rev. 2-09


    Gentamicin Piglet Label

    Gentamicin Piglet Onsert Label

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  • INGREDIENTS AND APPEARANCE
    GENTAMICIN PIGLET 
    gentamicin sulfate injection
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:58005-663
    Route of Administration INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN 5 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58005-663-04 100 mL in 1 VIAL
    2 NDC:58005-663-05 250 mL in 1 VIAL
    3 NDC:58005-663-06 500 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200394 07/31/2007
    Labeler - Sparhawk Laboratories, Inc. (147979082)
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