SPL Set ID: 094830ee-1b1c-4cf7-8a39-427dfd56f9c9

Estradiol vaginal inserts USP, 10 mcg, are small, white, film-coated inserts containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol, USP. Each insert of estradiol vaginal insert USP, 10 mcg contains the following excipients: corn starch, hypromellose, lactose monohydrate and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each estradiol vaginal insert, USP is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts, USP are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol, USP is released into the vagina. Estradiol hemihydrate is a white, almost white or colorless crystalline solid, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C 18 H 24 O 2 • ½ H 2 O with a molecular weight of 281.4. The structural formula is: 9ec90e26-figure-01