EstroGel is an estrogen indicated in the

1. Treatment of moderate to severe vasomotor symptoms due to menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

EstroGel 1.25 g is the single approved dose for the treatment of moderate to severe vasomotor symptoms and for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. The lowest effective dose of EstroGel for these indications has not been determined. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

When estrogen is prescribed for a postmenopausal woman with a uterus, generally, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (for example at 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

EstroGel is a clear, colorless, hydroalcoholic 0.06% estradiol gel supplied in a non-aerosol, metered-dose pump. The pump consists of an LDPE inner liner encased in rigid plastic with a resealable polypropylene cap. Three pump sizes are available, a 93-gram, a 50-gram, and a 25-gram. Each individually packaged 93-gram pump contains 93 grams of gel and is capable of delivering 64 metered 1.25-g doses. Each individually packaged 50-gram pump contains 50 grams of gel and is capable of delivering 32 metered 1.25-g doses. Each individually packaged 25-gram pump contains 25 grams of gel and is capable of delivering 14 metered 1.25-g doses.

NDC: 0051-1028-58.............(93-gram pump)
NDC: 17139-617-40.............(50-gram pump)
NDC: 17139-617-20.............(25-gram sample pump)
NDC: 0051-1028-20.............(25-gram sample pump)

Keep out of reach of children.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured for: ASCEND Therapeutics, Inc. Herndon, VA 20170 By Laboratoires Besins International Montrouge, France. FDA Rev date: 1/25/2008

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