AndroGel Storage, Stability & Shelf Life: Complete Clinical Guide

What is the storage temperature?

The AndroGel 1% label says to store at 25°C (77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F), referring to USP Controlled Room Temperature [1]. The patient Instructions for Use say to store AndroGel 1% at room temperature between 68°F and 77°F (20°C to 25°C) [1].

This is the AndroGel 1% label, which lists packets. The label says dosage and administration for AndroGel 1% differ from AndroGel 1.62%, and refers to the 1.62% prescribing information for that product [1].

What about heat exposure or freezing?

The label does not address heat or freezing beyond the temperature range above: a standard storage temperature of 25°C (77°F) and permitted excursions between 15°C and 30°C (59°F to 86°F) [1].

Shelf life and expiration

The label gives a storage temperature but no shelf-life period, so no number of months or years can be quoted from it [1].

Handling and disposal

AndroGel 1% comes in unit-dose aluminum foil packets in cartons of 30; a 2.5 g packet contains 25 mg of testosterone and a 5 g packet contains 50 mg [1]. The label says used packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets [1]. The patient instructions say AndroGel 1% is flammable until dry, to keep it away from fire, and to keep it and all medicines out of the reach of children [1].