FORTESTA (Page 7 of 7)

INSTRUCTIONS FOR USE

FORTESTA® (FOR-tes-ta) CIII

(testosterone)

Gel for topical use

Read this Instructions for Use for FORTESTA before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Applying FORTESTA:

• Apply FORTESTA only to areas that will be covered by shorts or pants.
• FORTESTA should be applied to the front and inner part of your thighs only. Do not apply FORTESTA to the area of the thigh closest to the scrotum. Do not apply FORTESTA to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms.
• Apply FORTESTA in the morning. If you shower or bathe, FORTESTA should be applied afterwards.
• Avoid swimming, showering, or bathing for at least 2 hours after you apply FORTESTA.
• FORTESTA is flammable until dry. Let FORTESTA dry before smoking or going near an open flame.
• Wash your hands with soap and water right after you apply FORTESTA.
• Before using a new canister of FORTESTA for the first time, you will need to prime the pump. To prime the FORTESTA pump, gently push down on the pump 8 times. Do not use any FORTESTA that comes out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your FORTESTA pump is now ready to use.
• Use FORTESTA exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you the dose of FORTESTA that is right for you.
• Press down on the pump to apply the medicine directly on clean, dry, skin that is not broken on the front and inner part of your thighs. Use 1 finger to gently rub FORTESTA evenly onto the front and inner part of each thigh.

• Let the application site dry completely before putting on shorts or pants.
• Wash your hands right away with soap and water.

How should I store FORTESTA?

• Store FORTESTA at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• When it is time to throw away the canister, safely throw away used FORTESTA in the household trash. Be careful to prevent accidental exposure of children or pets.
• Keep FORTESTA away from fire.
• Do not freeze FORTESTA.

Keep FORTESTA and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 05/2019

Container label

Package Label – Principle Display Panel – 60 g Canister Label

Package Label – Principle Display Panel – Principle Display Panel – 60 g Canister Carton

FORTESTA testosterone gel, metered

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-183 Route of Administration TOPICAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TESTOSTERONE (TESTOSTERONE) TESTOSTERONE 10 mg in 0.5 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL WATER ALCOHOL ISOPROPYL ALCOHOL OLEIC ACID TROLAMINE BUTYLATED HYDROXYTOLUENE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63481-183-16 1 CANISTER in 1 CARTON contains a CANISTER 1 60 g in 1 CANISTER This package is contained within the CARTON (63481-183-16) 2 NDC:63481-183-17 2 CANISTER in 1 CARTON contains a CANISTER 2 60 g in 1 CANISTER This package is contained within the CARTON (63481-183-17) 3 NDC:63481-183-18 3 CANISTER in 1 CARTON contains a CANISTER 3 60 g in 1 CANISTER This package is contained within the CARTON (63481-183-18)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021463 12/29/2010

Labeler — Endo Pharmaceuticals Inc. (178074951)

Revised: 01/2022 Endo Pharmaceuticals Inc.