Label: OVUGEL- triptorelin acetate gel

  • NDC Code(s): 51233-101-50
  • Packager: JBS United Animal Health II LLC (formerly, Pennatek LLC)
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated June 30, 2017

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

  • ACTIVE INGREDIENT:

    triptorelin acetate

  • DOSAGE FORM & STRENGTH:

    100 mcg triptorelin per mL (as triptorelin acetate)
    Gel for intravaginal use

  • INDICATIONS FOR USE:

    For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.  Not approved for use in gilts.  Safety and effectiveness have not been evaluated in these animals.

  • DESCRIPTION:

    OvuGel is a thin, clear to slightly hazy gel.  Each mL of OvuGel contains 100 mcg of triptorelin (as triptorelin acetate) for intravaginal administration.

  • WARNINGS:

    WITHDRAWAL PERIOD:
    No withdrawal period is required when used according to labeling.

    USER SAFETY WARNINGS:
    Not for Use in Humans.  Keep Out of Reach of Children.  The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.

    ANIMAL SAFETY WARNINGS:
    OvuGel should not be used in sows with obvious reproductive tract abnormalities.

  • RECOMMENDATIONS FOR SAFE AND EFFECTIVE USE:

    Use of a bottle mount multi-dose applicator is recommended to ensure accurate dosing.
    The use of adequate sperm numbers per insemination and proper semen storage, as recommended by the semen or artificial inseminator catheter suppliers, is recommended.

  • DIRECTIONS FOR USE:

    OvuGel should be administered intravaginally at approximately 96 hours after weaning.  The product should be warmed at room temperature for a minimum of 10 minutes prior to use.  Insert the delivery tube into the vagina so that the tip rests 1/2 inch (1-3 cm) posterior to the cervix.  Use a separate sheath over the delivery tube for each sow treated.  Each sow should receive a single 2 mL dose of OvuGel.  Sows should be inseminated 22 +/- 2 hours following administration of OvuGel using standard artificial insemination techniques.  Sows should be exposed to a boar during time of insemination.  (See end of package insert for more detailed directions for OvuGel administration).

  • STORAGE, HANDLING, AND DISPOSAL:

    Store at refrigerator temperature 36-46°F (2-8°C).  Excursions permitted to 77°F (25°C) for no more than 5 days during shipping.
    OvuGel should be administered within 1 hour of warming; unused portions may be refrigerated immediately after use.  The bottle stopper may be punctured a maximum of three times.  Discard 28 days after the stopper is first punctured.

  • HOW SUPPLIED:

    OvuGel is available in 52.5 mL multi-dose bottle (carton of 6).

  • QUESTIONS/COMMENTS:

    To obtain an MSDS, for technical assistance, or to report adverse events, contact JBS United Animal Health II at 888-842-7218 or www.ovugel.com.  For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary.

  • BOTTLE LABEL:

    image of bottle label

  • PACKAGE INSERT (FRONT):

    image of front of package insert

  • PACKAGE INSERT (BACK):

    image of back of package insert

  • CARTON:

    image of carton

  • CARTON (CONTINUED):

    image of carton (continued)

  • SHIPPING LABEL:

    image of shipping label

  • INGREDIENTS AND APPEARANCE
    OVUGEL 
    triptorelin acetate gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51233-101
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triptorelin Acetate (UNII: 43OFW291R9) (Triptorelin - UNII:9081Y98W2V) Triptorelin100 ug  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51233-101-5052.5 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14133902/08/2013
    Labeler - JBS United Animal Health II LLC (formerly, Pennatek LLC) (783511723)