OvuGel

Manufacturer
Aurora Pharmaceutical, Inc.
Effective date
2026-03-09
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:46:34

Label at a glance#

ProductOvuGel
Active ingredientTriptorelin Acetate
Label structure9 sections

Dosage and administration

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 sho...

Storage and handling

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

triptorelin acetate

DOSAGE FORM & STRENGTH:

DOSAGE FORMS & STRENGTHS SECTION

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

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

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:

DESCRIPTION SECTION

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:

WARNINGS SECTION

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:

GENERAL PRECAUTIONS SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

STORAGE AND HANDLING SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shipper label - case of 52.5 mL bottles

shipper labelshipper label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TRIPTORELIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9337e4c8-b17a-4e1a-88bb-852b6525db5cProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51072-140-00OvuGel52.5 mL in 1 BOTTLEGEL52.52

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51072-14051072-140-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
Triptorelin Acetate43OFW291R9ACTIM

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.