Label: MATRIX- altrenogest solution

WARNINGS:

WITHDRAWAL PERIODS
Animals intended for human consumption must not be slaughtered within 21 days of the last treatment with this drug product.

USER SAFETY WARNINGS:

Not for use in humans. Keep out of reach of children.

Skin contact must be avoided as MATRIX® is readily absorbed through unbroken skin, and exposure may result in serious side effects to both women and men. Always wear vinyl, neoprene, or nitrile protective gloves when handling MATRIX or when in contact with equipment or surfaces contaminated by this product. Latex gloves are not protective.

PREGNANT WOMEN OR WOMEN WHO MAY BE PREGNANT SHOULD NOT HANDLE MATRIX® (altrenogest). WOMEN OF CHILDBEARING AGE SHOULD EXERCISE EXTREME CAUTION WHEN HANDLING THIS PRODUCT.

Accidental absorption, such as absorption through the skin, could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Wash off accidental spillage on the skin immediately with soap and water. Any equipment or surfaces that come in contact with MATRIX® should be adequately cleaned and decontaminated to prevent human exposure.

Always use the MATRIX® Dosing Device to administer this product. The MATRIX® bottle is designed only for use with the MATRIX® Dosing Device. Use without the device increases the risk of human exposure.

PEOPLE WHO SHOULD NOT HANDLE MATRIX®:1

1. Women who are or may be pregnant.
2. Anyone with blood clots or clotting disorders, or with a history of these events.
3. Anyone with a history of heart disease or stroke.
4. Women with known or suspected breast cancer.
5. People with known or suspected estrogen-dependent cancer.
6. Women with vaginal bleeding of unknown cause.
7. People with tumors which developed during the use of oral contraceptives or other estrogen-containing products.
8. Anyone with liver dysfunction or disease.

1

Based on known effects of long-term progestin use in humans.

ACCIDENTAL EXPOSURE:

MATRIX® is readily absorbed from contact with the skin. In addition, this oil-based product can penetrate latex or other types of porous gloves. Always wear vinyl, neoprene, or nitrile protective gloves when handling MATRIX®. Latex gloves are not protective. If MATRIX®  gets inside gloves by damage or spilling, the covered skin may absorb more of the drug. Side effects after a single exposure are possible; however, continued daily exposure has the potential for more serious effects.

IN CASE OF ACCIDENTAL EXPOSURE:

Skin exposure and/or clothing contamination: Wash skin immediately with soap and water, and launder clothing with detergent.

Eye exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses.

If swallowed: Do not induce vomiting. Seek medical attention immediately. MATRIX® contains an oil. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the labeling to the physician.

Reported HUMAN Effects from Exposure:

Side effects have been reported in women and men following accidental exposure to altrenogest products, including MATRIX®, either through handling of the product or contact with contaminated surfaces.

• Reproductive side effects reported in women included abnormal or absent menstrual cycles.
• Reproductive side effects in men included decreased libido.
• Other side effects reported in women and men included headaches, fever, abdominal pain, nausea, diarrhea, vomiting, and rashes.

STORAGE, HANDLING, AND DISPOSAL:

Store MATRIX® solution bottle and Dosing Device when loaded with solution for continued use at or below room temperature, 77°F (25°C). Close tightly. Refer to the MATRIX® Dosing Device label for equipment cleaning instructions. Place empty drug containers, waste from rinsing the Dosing Device, protective gloves, or other articles that contact this product in a leak-resistant container for disposal in accordance with applicable Federal, state, and local regulations.