ESTROGEL Gel Ref.[10809] Active ingredients: Estradiol

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

EstroGel (estradiol gel) contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of EstroGel delivers 1.25 g of gel containing 0.75 mg estradiol.

Estradiol is a white crystalline powder, chemically described as estraโ€‘1,3,5(10)-triene-3,17ฮฒ-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39.

The structural formula is:

The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol, triethanolamine and carbomer 934P) are pharmacologically inactive.

Dosage Forms and Strengths

EstroGel 0.06% is an estradiol transdermal gel. One pump depression delivers 1.25 g of gel that contains 0.75 mg estradiol.

How Supplied

EstroGel is a clear, colorless, hydroalcoholic 0.06 percent estradiol gel supplied in a nonโ€‘aerosol, metered-dose pump. The pump consists of an LDPE inner liner encased in rigid plastic with a resealable polypropylene cap. EstroGel is available in a 50-gram (1.75 oz) size. Each individually packaged 50-gram pump contains 50 grams of gel and can deliver 30 metered 1.25-g doses.

NDC: 17139-617-40 (50-gram pump)

Manufactured for: ASCEND Therapeutics US, LLC, Herndon, VA 20170

By DPT Laboratories Ltd., San Antonio, TX 78215

Drugs

Drug Countries
ESTROGEL Austria, Canada, Ecuador, Finland, United States

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