actually [0.0001:<0.0001 2 Sprays Evamist (N=74) 2.54 (0.21) -0.57 (0.83) -0.92 (1.01) Placebo (N=76) 2.54 (0.22) -0.25 (0.64) -0.54 (0.89) Difference c - -0.32 -0.38 p-value d - 0.0160 0.0406 3 Sprays Evamist (N=76) 2.58 (0.25) -0.43 (0.66) -1.07 (1.01) Placebo (N=75) 2.54 (0.24) -0.13 (0.53) -0.31 (0.75) Difference c - -0.30 -0.76 p-value d - 0.0031> <0.0001 a Severity score calculated as: (2 x number moderate +3 x number severe)/ number moderate + number severe) b Mean change and difference based on raw data c Evamist versus placebo d Tests for pairwise differences using ANCOVA Women s Health Initiative Studies The WHI enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily oral CE (0.625 mg)-alone or in combination with MPA (2.5 mg) compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of CHD (defined as nonfatal MI, silent MI and CHD death), with invasive breast cancer as the primary adverse outcome. A global index included the earliest occurrence of CHD, invasive breast cancer, stroke, PE, endometrial cancer (only in the CE plus MPA substudy), colorectal cancer, hip fracture, or death due to other cause. These substudies did not evaluate the effects of CE-alone or CE plus MPA on menopausal symptoms. WHI Estrogen-Alone Substudy The WHI estrogen-alone substudy was stopped early because an increased risk of stroke was observed, and it was deemed that no further information would be obtained regarding the risks and benefits of estrogen-alone in predetermined primary endpoints. Results of the estrogen-alone substudy, which included 10,739 women (average 63 years of age, range 50 to 79 years of age; 75.3 percent White, 15.1 percent Black, 6.1 percent Hispanic, 3.6 percent Other), after an average follow-up of 7.1 years are presented in Table 5. Table 5. Relative and Absolute Risk Seen in the Estrogen Alone Substudy of WHI a Event Relative Risk CE vs. Placebo (95%) nCI b ) CE (n = 5,310) Placebo (n = 5,429) Absolute Risk per 10,000 Women-Years CHD events c Non-fatal MI c CHD death c 0.95 (0.78-1.16) 0.91 (0.73-1.14) 1.01 (0.71-1.43) 54 40 16 57 43 16 All strokes c Ischemic stroke c 1.33 (1.05-1.68) 1.55 (1.19-2.01) 45 38 33 25 Deep vein thrombosis c,d 1.47 (1.06-2.06) 23 15 Pulmonary embolism c 1.37 (0.90-2.07) 14 10 Invasive breast cancer c 0.80 (0.62-1.04) 28 34 Colorectal cancer e 1.08 (0.75-1.55) 17 16 Hip facture c 0.65 (0.45-0.94) 12 19 Vertebral fractures c,d 0.64 (0.44-0.93) 11 18 Lower arm/wrist fractures c,d 0.58 (0.47-0.72) 35 59 Total fractures c,d 0.71 (0.64-0.80) 144 197 Death due to other causes e,f 1.08 (0.88-1.32) 53 50 Overall mortality c,d 1.04 (0.88-1.22) 79 75 Global index g 1.02 (0.92-1.13) 206 201 a Adapted from numerous WHI publications. WHI publications can be viewed at www.nhlbi.nih.gov/whi. b Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. c Results are based on centrally adjudicated data for an average follow-up of 7.1 years. d Not included in global index . e Results are based on an average follow-up of 6.8 years. f All deaths, except from breast or colorectal cancer, definite or probable CHD, PE or cerebrovascular disease. g A subset of the events was combined in a global index , defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, PE, endometrial cancer, colorectal cancer, hip fracture, or death due to other causes. For those outcomes included in the WHI global index that reached statistical significance, the absolute excess risk per 10,000 women-years in the group treated with CE-alone was 12 more strokes, while the absolute risk reduction per 10,000 women-years was 7 fewer hip fractures. 9 The absolute excess risk of events included in the global index was a non-significant 5 events per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality. No overall difference for primary CHD events (nonfatal MI, silent MI and CHD death) and invasive breast cancer incidence in women receiving CE-alone compared to placebo was reported in final centrally adjudicated results from the estrogen-alone substudy, after an average follow-up of 7.1 years. Centrally adjudicated results for stroke events from the estrogen-alone substudy, after an average follow-up of 7.1 years, reported no significant differences in distribution of stroke subtypes or severity, including fatal strokes, in women receiving CE-alone compared to placebo. Estrogen-alone increased the risk for ischemic stroke, and this excess risk was present in all subgroups of women examined. 10 Timing of the initiation of estrogen-alone therapy relative to the start of menopause may affect the overall risk benefit profile. The WHI estrogen-alone substudy stratified by age showed in women 50 to 59 years of age a non-significant trend toward reduced risk for CHD [ hazard ratio (HR) 0.63 (95 percent CI, 0.36-1.09)] and overall mortality [HR 0.71 (95 percent CI, 0.46-1.11) ]. WHI Estrogen Plus Progestin Substudy The WHI estrogen plus progestin substudy was stopped early. According to the predefined stopping rule, after an average follow-up of 5.6 years of treatment, the increased risk of invasive breast cancer and cardiovascular events exceeded the specified benefits included in the global index . The absolute excess risk of events included in the global index was 19 per 10,000 women-years. For those outcomes included in the WHI global index that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women-years in the group treated with CE plus MPA were 7 more CHD events, 8 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reduction per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures. Results of the CE plus MPA substudy which included 16,608 women (average 63 years of age; range 50 to 79 years of age: 83.9 percent White, 6.5 percent Black, 5.4 percent Hispanic, 3.9 percent Other) are presented in Table 6. These results reflect centrally adjudicated data after an average follow-up of 5.6 years. Table 6. Relative and Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 Years a,b Event Relative Risk CE/MPA vs. Placebo (95%) nCI c ) CE/MPA (n = 8,506) Placebo (n = 8,102) Absolute Risk per 10,000 Women-Years CHD events Non-fatal MI CHD death c 1.23 (0.99-1.53) 1.28 (1.00-1.63) 1.10 (0.70-1.75) 41 31 8 34 25 8 All strokes Ischemic stroke 1.31 (1.03-1.68) 1.44 (1.09-1.90) 33 26 25 18 Deep vein thrombosis d 1.95 (1.43-2.67) 26 13 Pulmonary embolism 2.13 (1.45-3.11) 18 8 Invasive breast cancer e 1.24 (1.01-1.54) 41 33 Colorectal cancer 0.61 (0.42-0.87) 10 16 Endometrial cancer d 0.81 (0.48-1.36) 6 7 Cervical cancer d 1.44 (0.47-4.42) 2 1 Hip facture 0.67 (0.47-0.96) 11 16 Vertebral fractures d 0.65 (0.46-0.92) 11 17 Lower arm/wrist fractures d 0.71 (0.59-0.85) 44 62 Total fractures d 0.76 (0.69-0.83) 152 199 Overall mortality f 1.00 (0.83-1.19) 52 52 Global index g 1.13 (1.02-1.25) 184 165 a Adapted from numerous WHI publications, WHI publications can be viewed at www.nhlbi.nih.gov/whi b Results are based on centrally adjudicated data. c Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. d Not included in global index . e Includes metastatic and non-metastatic breast cancer, with the exception of in situ breast cancer. f All deaths, except from breast or colorectal cancer, definite or probably CHD, PE or cerebrovascular disease. g A subset of the events was combined in a global index , defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, PE, endometrial cancer, colorectal cancer, hip fracture, or death due to other causes. Timing of the initiation of estrogen plus progestin therapy relative to the start of menopause may affect the overall risk benefit profile. The WHI estrogen plus progestin substudy stratified by age showed in women 50 to 59 years of age a non-significant trend toward reduced risk for overall mortality [HR 0.69 (95 percent CI, 0.44-1.07)]. Women s Health Initiative Memory Study The WHIMS estrogen-alone ancillary study of the WHI, enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age (45 percent were 65 to 69 years of age, 36 percent were 70 to 74 years of age, and 19 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) on the incidence of probable dementia (primary outcome) compared to placebo. After an average follow-up of 5.2 years, the relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83-2.66). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years. Probable dementia as defined in this study included Alzheimer s disease (AD), vascular dementia (VaD) and mixed type (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [ see Warnings and Precautions (5.3) and Use in Specific Populations (8.5) ]. The WHIMS estrogen plus progestin ancillary study enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent were 65 to 69 years of age, 35 percent were 70 to 74 years of age, and 18 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) plus MPA (2.5 mg) on the incidence of probable dementia (primary outcome) compared to placebo. After an average follow-up of 4 years, the relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.12-3.48). The absolute risk of probable dementia for CE plus MPA versus placebo was 45 versus 22 per 10,000 women-years. Probable dementia as defined in this study included AD, VaD and mixed type (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [ see Warnings and Precautions (5.3), and Use in Specific Populations (8.5) ]. When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, 1.19-2.60). Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women [ see Warnings and Precautions (5.3), and Use in Specific Populations (8.5) ]. REFERENCES 1. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA . 2007:297;1465-1477. 2. Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med . 2006;166:357 365. 3. Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med . 2006;166:772-780. 4. Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. JAMA . 2004:292;1573-1580. 5. Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women with Hysterectomy. JAMA . 2006;295:1647-1657. 6. Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA . 2003:289;3234-3253. 7. Anderson GL, et al. Effects of Estrogen Plus Progestin in Gynecologic Cancers and Associated Diagnostic Procedures. JAMA . 2003:290;1739-1748. 8. Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA. 2004:291;2947-2958. 9. Jackson RD, et al. Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women with Hysterectomy: Results from the Women s Health Initiative Randomized Trial. J Bone Miner Res . 2006:21;817-828. 10. Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women s Health Initiative. Circulation . 2006:113;2425-2434. How Supplied/Storage and Handling How Supplied Evamist (NDC 0574-2067-27) is supplied as a homogeneous solution of estradiol USP, octisalate USP and alcohol USP. The liquid formulation of Evamist is packaged in a glass vial fitted with a metered-dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered-dose spray. Each metered-dose pump contains 8.1 mL and is designed to deliver 56 sprays of 90 mcL after priming. One spray contains 1.53 mg estradiol. Storage and Handling Keep out of reach of children. Alcohol and alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has dried. Store at room temperature 20 C to 25 C (68 F to 77 F); excursion permitted between 15 C to 30 C (59 F to 86 F). Do not freeze. Patient Counseling Information See FDA-approved patient labeling (Patient Information and Instructions for Use) Vaginal Bleeding Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare provider as soon as possible [ see Warnings and Precautions (5.2) ]. Unintentional Secondary Exposure to Evamist Provide the following information about secondary exposure to Evamist: Apply Evamist as directed and keep children from contacting exposed application site(s). If direct contact with the application site occurs, the contact area should be washed thoroughly with soap and water. Women should cover the Evamist application site, after the 2 minute drying period, with clothing if another person may come in contact with that area of skin. [See FDA-Approved Patient Information Leaflet at the end of the prescribing information.] Look for signs of unexpected sexual development, such as breast mass or increased breast size in prepubertal children. If signs of unintentional secondary exposure are noticed: o Have children evaluated by a healthcare provider. o Discontinue Evamist until the cause(s) is identified for any unexpected sexual development in children under their care. o Women should contact their healthcare provider and discuss the appropriate use and handling of Evamist when around children. o If conditions for safe use cannot be met, Evamist should be discontinued and alternative treatments for menopausal signs and symptoms should be considered. Pets may also be unintentionally exposed to Evamist if above precautions are not followed. Possible Serious Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of the possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [ see Warnings and Precautions (5.1, 5.2, 5.3) ]. Possible Less Serious but Common Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting. Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215 Manufactured For Perrigo Minneapolis, MN 55427 6X200 RC J4 Rev 11-17 D PATIENT INFORMATION Evamist (EE-vuh-mist) (estradiol transdermal spray) Read this Patient Information before you start using Evamist and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. What is the most important information I should know about Evamist (an estrogen hormone)? Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Evamist. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause. Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function). Using estrogen-alone may increase your chances of getting strokes or blood clots. Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years or older. Do not use estrogens with progestins to prevent heart disease, heart attack, strokes, or dementia. Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years and older. The estrogen in Evamist spray can transfer from the area of skin where it was sprayed to other people. Do not allow others, especially children, to come into contact with the area of your skin where you sprayed Evamist. Young children who are accidentally exposed to estrogen through contact with women using Evamist may show signs of puberty that are not expected (for example, breast budding). You and your healthcare provider should talk regularly about whether you still need treatment with Evamist. What is Evamist? Evamist is a prescription medicine spray that contains estradiol (an estrogen hormone). What is Evamist used for? Evamist spray is used after menopause to: Reduce moderate to severe hot flashes Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the change of life or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes surgical menopause. When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ( hot flashes or hot flushes ). In some women, the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Evamist. Who should not use Evamist? Do not start using Evamist if you: have unusual vaginal bleeding Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. currently have or have had certain cancers Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Evamist. had a stroke or heart attack currently have or have had blood clots currently have or have had liver problems have been diagnosed with a bleeding disorder are allergic to Evamist or any of its ingredients See the list of ingredients in Evamist at the end of this leaflet think you may be pregnant Evamist is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use Evamist if the test is positive and talk to your healthcare provider. What should I tell my healthcare provider before I use Evamist? Before you use Evamist, tell your healthcare provider if you: have any unusual vaginal bleeding Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any vaginal bleeding to find out the cause. have any other medical conditions Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. are going to have surgery or will be on bed rest Your healthcare provider will let you know if you need to stop using Evamist. are breast feeding The hormone in Evamist can pass into your breast milk. Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect how Evamist works. Evamist may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How should I use Evamist? For detailed instructions, see the step-by-step instructions for using Evamist at the end of this Patient Information. Use Evamist exactly as your healthcare provider tells you to use it. Evamist is for skin use only. Apply Evamist at the same time each day. If you use sunscreen 1 hour after you use Evamist, it may reduce the amount of Evamist absorbed by your skin. The estrogen in Evamist spray can transfer from the area of skin where it was sprayed to other people or pets. Do not allow other people, especially children to come into contact with the area of your skin where you have sprayed Evamist. If another person accidentally touches the area of your skin where you have sprayed Evamist, that area of their skin should be washed with soap and water right away. Do not let pets lick or touch your arm where you have sprayed Evamist, especially small pets. Evamist may harm them. Cover your skin with clothing where you have sprayed Evamist if you think a pet could come in contact with that area of your skin. If a pet accidentally comes in contact with the area of your skin where you have sprayed Evamist, the area of the pet s skin should be washed with soap and water right away. Young children who are accidentally exposed to estrogen through contact with women using Evamist may show signs and symptoms of puberty that are not expected. Signs and symptoms in children of exposure to Evamist may include: o breast budding or breast lumps o other signs of abnormal sexual development If a child shows signs and symptoms of accidental exposure to Evamist: o have the child checked right away by their healthcare provider. o stop using Evamist and call your healthcare provider right away. o talk to your healthcare provider about the correct use of Evamist when around children. Talk to your healthcare provider about other treatments for your menopause symptoms if accidental exposure to Evamist cannot be avoided. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Evamist. What should I avoid while using Evamist? Do not allow others to make contact with the area of skin where you have applied the Evamist spray. Evamist contains alcohol, which is flammable. Avoid fire, flame, or smoking until the area of your skin where you have applied Evamist has dried. What are the possible side effects of Evamist? Side effects are grouped by how serious they are and how often they happen when you are treated. Serious, but less common side effects include: heart attack stroke blood clots dementia breast cancer cancer of the lining of the uterus (womb) cancer of the ovary high blood pressure high blood sugar gallbladder disease liver problems changes in your thyroid hormone levels enlargement of benign tumors of the uterus ( fibroids ) Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: new breast lumps unusual vaginal bleeding changes in vision or speech sudden new severe headaches severe pains in your chest or legs with or without shortness of breath, weakness and fatigue Less serious, but common side effects include: headache breast pain irregular vaginal bleeding or spotting stomach or abdominal cramps, bloating nausea and vomiting hair loss fluid retention vaginal yeast infection These are not all the possible side effects of Evamist. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may report side effects to Perrigo at 1-866-634-9120 or to FDA at 1-800-FDA-1088. What can I do to lower my chances of a serious side effect with Evamist? Talk with your healthcare provider regularly about whether you should continue using Evamist. If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while using Evamist. Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease. How should I store Evamist? Store Evamist at room temperature 68 F to 77 F (20 C to 25 C) Do not freeze. Safely throw away medicine that is out of date or no longer needed. Keep Evamist and all medicines out of the reach of children. General information about the safe and effective use of Evamist. Medicines are sometimes prescribed for conditions other than those listed in patient information leaflets. Do not use Evamist for conditions for which it was not prescribed. Do not give Evamist to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about Evamist. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Evamist that is written for health professionals. For more information, go to www.Evamist.com or call Perrigo at 1-866-634-9120. What are the ingredients in Evamist? Active ingredient: estradiol Inactive ingredients: octisalate, alcohol Instructions for Use Evamist (EE-vuh-mist) (estradiol transdermal spray) Read this Instructions for Use before you start using Evamist and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms of your treatment. The parts of your Evamist applicator Evamist comes in a spray applicator that delivers a measured amount of estradiol to your skin with each spray (see Figure A). Step 1. Priming your Evamist Before you use your Evamist applicator for the first time, the applicator must be primed. Hold the Evamist applicator upright. Keep the cover on. Fully press down the pump button 3 times with your thumb or index finger (see Figure B). After priming, the Evamist applicator is ready to use. The Evamist applicator should be primed only 1 time when you first start using a new applicator. Do not prime the Evamist applicator before your dose each day. Step 2. Using your Evamist Remove the plastic cover. Apply Evamist to a clean, dry, unbroken skin area on the inside of your forearm between the elbow and the wrist (see Figure C). This area must be clean, dry, and the skin must be without open wounds, cuts, abrasions, or rashes. Hold the Evamist applicator upright and rest the plastic cone flat against your skin. You may need to change the position of your arm or the position of the cone on your arm so that the cone is flat against your skin and there are no gaps between the cone and your skin (see Figure C). Press the pump button down fully 1 time (see Figure C). If your healthcare provider tells you to increase your dose to 2 or 3 sprays, move the cone before applying the second or third spray to an area of your skin next to but not touching the area of the previous spray (see Figure D). Do not apply Evamist to your breasts or in and around your vagina. Do not massage or rub Evamist into your skin. Let Evamist spray dry on your skin for at least: o 2 minutes before you cover your skin with clothing. o 1 hour before you wash your skin. Step 3. After you use Evamist Place the plastic cover back on the Evamist applicator cone. Evamist is flammable until dry. Avoid fire, flame, or smoking until the area of your skin where you have applied Evamist has completely dried. Step 4. Throwing away used Evamist applicators Your Evamist applicator contains enough medicine to allow for initial priming of the pump with 3 sprays and application of 56 sprays. Do not use your Evamist applicator for more than 56 application sprays even though the bottle may not be completely empty. You may not get the correct dose. Always replace the cover over the cone of your Evamist applicator before you throw it away to prevent accidental exposure to other people or pets. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Manufactured by DPT Laboratories. Ltd San Antonio, TX 78215 Manufactured For Perrigo Minneapolis, MN 55427 6X200 RC J4 Rev 11-17 D PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0574- 2067 -27 FOR TOPICAL USE ONLY Evamist (estradiol transdermal spray) Each spray contains 1.53 mg of estradiol 0.27 fl oz (8.1 mL) Rx Only Package/Label Display Panel- Professional Sample NDC 0574 -2067- 00 FOR TOPICAL USE ONLY Evamist (estradiol transdermal spray) Each spray contains 1.53 mg of estradiol PROFESSIONAL SAMPLE NOT TO BE SOLD 0.27 fl oz (8.1 mL) Rx Only Evamist estradiol spray Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0574-2067 Route of Administration TRANSDERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL (ESTRADIOL) ESTRADIOL 1.53 mg Inactive Ingredients Ingredient Name Strength OCTISALATE ALCOHOL Packaging # Item Code Package Description 1 NDC:0574-2067-27 56 SPRAY in 1 VIAL, MULTI-DOSE 2 NDC:0574-2067-00 56 SPRAY in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022014 04/11/2015 Labeler - Paddock Laboratories, LLC (967694121) Revised: 11/2017 Paddock Laboratories, LLC Next Interactions Print this page Add to My Med List More about Evamist (estradiol) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 16 Reviews Add your own review/rating Drug class: estrogens Consumer resources Evamist Evamist for use on skin Evamist Transdermal (Advanced Reading) Professional resources Estradiol (AHFS Monograph) Estradiol Valerate Injection (FDA) Other brands: Estrace , Estradiol Patch , Climara , Vivelle , ... +11 more Related treatment guides Postmenopausal Symptoms> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Ther-Rx Corporation Drug Class Estrogens Related Drugs estrogens estradiol topical , Premarin , Estrace , Vagifem Postmenopausal Symptoms estradiol , Premarin , Estrace , Prempro , conjugated estrogens topical , Climara , Estrogel , Vivelle , Premarin Vaginal , Vivelle-Dot , Menest , Minivelle , Estratest , Delestrogen , Activella , Femring , Lopreeza , CombiPatch , estradiol / norethindrone , Divigel , Mimvey , Alora , More... Evamist Rating 16 User Reviews 8.1 /10 16 User Reviews 8.1 Rate it!} } probably the greatest
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