Use the special applicator supplied with the cream. trailer << /Size 297 /Info 276 0 R /Root 282 0 R /Prev 745113 /ID[ 0000010061 00000 n 0000017781 00000 n 0000002789 00000 n Estradiol transdermal system (twice-weekly) should be replaced twice weekly. 0000002523 00000 n Estradiol (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. 0000009994 00000 n How is this medicine (Estradiol Vaginal Insert) best taken? 0000020702 00000 n Each Estradiol Vaginal Insert is contained in a disposable, single-use applicator, packaged in a blister pack. 0000002308 00000 n 0000009813 00000 n 0000028912 00000 n 0000016237 00000 n 0000012829 00000 n 0000002080 00000 n Read all information given to you. 0000029086 00000 n Use estradiol vaginal insert as ordered by your doctor. 0000006968 00000 n 0000018400 00000 n 0000000016 00000 n 0000016875 00000 n 0000029755 00000 n Do not take estradiol vaginal insert by mouth. 0000026505 00000 n 0000003905 00000 n The product information provided in this site is intended only for consumers in the United States. 0000008967 00000 n 0000043469 00000 n 0000004570 00000 n Follow all instructions closely. 0000003281 00000 n 0000001928 00000 n 0000016679 00000 n 0000013131 00000 n 0000009258 00000 n 0000008427 00000 n 0000026717 00000 n < 1817 56 0000009747 00000 n Mylan manufactures ESTRADIOL VAGINAL CREAM, USP, 0.01% (Estrace) in strengths of 001 %PDF-1.3 %���� xref 0000026324 00000 n 0000010785 00000 n 0000010216 00000 n 2 DESCRIPTION Each gram of Premarin® (conjugated estrogens) Vaginal Cream contains 0.625 mg conjugated estrogens, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium 0000017186 00000 n For vaginal use only. 0000025775 00000 n 0000004910 00000 n 0000019037 00000 n 0000001754 00000 n Insert the applicator into the vagina and push the plunger to expel the cream … 0000008251 00000 n 0000012483 00000 n 0000037293 00000 n 0000002829 00000 n 0000001732 00000 n 281 0 obj << /Linearized 1 /O 283 /H [ 728 1026 ] /L 750863 /E 74643 /N 25 /T 745124 >> endobj xref 281 16 0000000016 00000 n 0000005767 00000 n 0000027382 00000 n NDA20-655/S-008 Page 4 4 Alora® (estradiol transdermal system) Continuous Delivery for Twice Weekly Dosing Lie on your back, part and bend your knees. The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site. 0000020296 00000 n %PDF-1.5 %���� 0000009565 00000 n 0000029417 00000 n 0000003085 00000 n Fill the applicator with the prescribed amount of cream. If you are 65 or older, use estradiol vaginal insert with care. 0000000728 00000 n 0000012620 00000 n 0000019665 00000 n The area selected should not be oily, damaged, or irritated. 1817 0 obj <> endobj The waistline . Estradiol Matrix Transdermal Delivery System NDA 20-655/S-008 Package Insert Watson Laboratories Inc. Research Park 417 Wakara Way Salt Lake City, UT 84108 USA. Wash hands before and after use. 0000027720 00000 n The film coating contains hypromellose and polyethylene glycol. 0000011324 00000 n Read package directions carefully before using. The product discussed on this site may have different product labeling outside of the United States. Each Estradiol Vaginal Insert, 10 mcg contains the following excipients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, and magnesium stearate. 0000012665 00000 n You could have more side effects. 0000008928 00000 n It has an empirical formula of C18H24O2 and molecular weight of 272.37. The structural formula is: 0000007613 00000 n 0000011237 00000 n ESTRACE (estradiol tablets, USP) for oral administration contains 0.5, 1 or 2 mg of micronized estradiol per tablet. 0000004400 00000 n 0000014951 00000 n 0000027051 00000 n 0000004770 00000 n 0000000671 00000 n 0000003917 00000 n trailer Each gram of ESTRACE (estradiol vaginal cream, USP, 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purif ied water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone.