recommend [1:<0.05. Frequency of Daily Hot Flushes Baseline Median 9.72 9.24 9.64 9.32 Median Change: Week 4 -5.00 -5.73 -7.20 -3.63 p-value * 0.132 0.011> <0.001 Median Change: Week 7 -6.62 -7.14 -7.71 -4.37 p-value *> <0.001> <0.001> <0.001 Median Change: Week 12 -6.88 -7.29 -8.35 -4.48 p-value *> <0.001> <0.001> <0.001 Severity of Daily Hot Flushes Baseline Median 2.52 2.51 2.52 2.54 Median Change: Week 4 -0.07 -0.18 -0.47 -0.04 p-value * 0.283> <0.001> <0.001 Median Change: Week 7 -0.24 -0.46 -1.06 -0.06 p-value *> <0.001> <0.001> <0.001 Median Change: Week 12 -0.33 -0.56 -1.69 -0.13 p-value * 0.021 0.002> <0.001 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; 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 4. Table 4: Relative And Absolute Risk Seen In The Estrogen-Alone Substudy Of WHI * Event Relative Risk CE vs. Placebo CE n = 5,310 Placebo n = 5,429 (95% nCI ) Absolute Risk per 10,000 Women-Years * Adapted from numerous WHI publications. WHI publications can be viewed at www.nhlbi.nih.gov/whi. Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. Results are based on centrally adjudicated data for an average follow-up of 7.1 years. Not included in "global index". Results are based on an average follow-up of 6.8 years. # All deaths, except from breast or colorectal cancer, definite or probable CHD, PE or cerebrovascular disease. Þ A subset of the events was combined in a "global index", defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, or death due to other causes. CHD events 0.95 (0.78 1.16) 54 57 Nonfatal MI 0.91 (0.73 1.14) 40 43 CHD death 1.01 (0.71 1.43) 16 16 All strokes 1.33 (1.05 1.68) 45 33 Ischemic stroke 1.55 (1.19 2.01) 38 25 Deep vein thrombosis , 1.47 (1.06 2.06) 23 15 Pulmonary embolism 1.37 (0.90 2.07) 14 10 Invasive breast cancer 0.80 (0.62 1.04) 28 34 Colorectal cancer 1.08 (0.75 1.55) 17 16 Hip fracture 0.65 (0.45 0.94) 12 19 Vertebral fractures , 0.64 (0.44 0.93) 11 18 Lower arm/wrist fractures , 0.58 (0.47 0.72) 35 59 Total fractures , 0.71 (0.64 0.80) 144 197 Death due to other causes , # 1.08 (0.88 1.32) 53 50 Overall mortality , 1.04 (0.88 1.22) 79 75 Global index Þ 1.02 (0.91 1.13) 206 201 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 nonsignificant 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 with 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 difference in distribution of stroke subtype 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 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 reductions 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; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other), are presented in Table 5. These results reflect centrally adjudicated data after an average follow-up of 5.6 years. Table 5: Relative And Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 Years * , Event Relative Risk CE/MPA vs. Placebo CE/MPA n = 8,506 Placebo n = 8,102 (95% nCI ) Absolute Risk per 10,000 Women-Years * Adapted from numerous WHI publications. WHI publications can be viewed at www.nhlbi.nih.gov/whi. Results are based on centrally adjudicated data. Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. Not included in "global index". Includes metastatic and non-metastatic breast cancer, with the exception of in situ breast cancer. # All deaths, except from breast or colorectal cancer, definite or probable CHD, PE or cerebrovascular disease. Þ A subset of the events was combined in a "global index", defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, or death due to other causes. CHD events 1.23 (0.99 1.53) 41 34 Non-fatal MI 1.28 (1.00 1.63) 31 25 CHD death 1.10 (0.70 1.75) 8 8 All strokes 1.31 (1.03 1.68) 33 25 Ischemic stroke 1.44 (1.09 1.90) 26 18 Deep vein thrombosis 1.95 (1.43 2.67) 26 13 Pulmonary embolism 2.13 (1.45 3.11) 18 8 Invasive breast cancer 1.24 (1.01 1.54) 41 33 Colorectal cancer 0.61 (0.42 0.87) 10 16 Endometrial cancer 0.81 (0.48 1.36) 6 7 Cervical cancer 1.44 (0.47 4.42) 2 1 Hip fracture 0.67 (0.47 0.96) 11 16 Vertebral fractures 0.65 (0.46 0.92) 11 17 Lower arm/wrist fractures 0.71 (0.59 0.85) 44 62 Total fractures 0.76 (0.69 0.83) 152 199 Overall mortality # 1.00 (0.83 1.19) 52 52 Global Index Þ 1.13 (1.02 1.25) 184 165 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 for 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 WHI enrolled 2,947 predominantly healthy postmenopausal women 65 to 79 years of age (45 percent were 65 to 69 year 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)-alone 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 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 was 2.05 (95 percent CI, 1.21 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 Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA . 2007;297:1465 1477. Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med . 2006;166:357 365. Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med . 2006;166:772 780. Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. JAMA . 2004;292:1573 1580. 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. Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA . 2003;289:3234 3253. Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. JAMA. 2003;290:1739 1748. Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA . 2004;291:2947 2958. 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. Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women's Health Initiative. Circulation . 2006;113:2425 2434. How is Divigel Supplied How Supplied Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 0.25, 0.5, and 1.0 g, corresponding to 0.25, 0.5, and 1.0 mg estradiol, respectively. NDC 68025-065-30, carton of 30 packets, 0.25 mg estradiol per single-dose foil packet NDC 68025-066-30, carton of 30 packets, 0.5 mg estradiol per single-dose foil packet NDC 68025-067-30, carton of 30 packets, 1.0 mg estradiol per single-dose foil packet Keep out of the reach of children. Storage and Handling 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.] Patient Counseling Information See FDA-Approved Patient Labeling . Vaginal Bleeding Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider as soon as possible [ see Warnings and Precautions (5.2) ]. Possible Serious Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of 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 More Common Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headaches, breast pain and tenderness, nausea and vomiting. Instructions for Use Divigel should be applied once a day, around the same time each day Apply Divigel to clean, dry, and unbroken (without cuts or scrapes) skin. If you take a bath or shower, be sure to apply your Divigel after your skin is dry. The application site should be completely dry before dressing or swimming Apply Divigel to either your left or right upper thigh. Change between your left and right upper thigh each day to help prevent skin irritation TO APPLY: Step 1: Wash and dry your hands thoroughly. Step 2: Sit in a comfortable position. Step 3: Cut or tear the Divigel packet as shown in Figure A. Figure A Step 4: Using your thumb and index finger, squeeze the entire contents of the packet onto the skin of the upper thigh as shown in Figure B. Figure B Step 5: Gently spread the gel in a thin layer on your upper thigh over an area of about 5 by 7 inches, or two palm prints as shown in Figure C. It is not necessary to massage or rub in Divigel. Figure C Step 6: Allow the gel to dry completely before dressing. Step 7: Dispose of the empty Divigel packet in the trash. Step 8: Wash your hands with soap and water immediately after applying Divigel to remove any remaining gel and reduce the chance of transferring Divigel to other people. 125140-08 Revised 11/2017 FDA-APPROVED PATIENT LABELING FDA-Approved Patient Labeling Divigel (estradiol gel) 0.1% Read this PATIENT INFORMATION leaflet before you start using Divigel and read what you get each time you refill your Divigel prescription. 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 Divigel (AN ESTROGEN HORMONE)? Using estrogen-alone increases your chance of getting cancer of the uterus (womb) Report any unusual vaginal bleeding right away while you are using Divigel. 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. Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of 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 of age or older Do not use estrogens with progestins to prevent heart disease, heart attacks, 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 of age or older You and your healthcare provider should talk regularly about whether you still need treatment with Divigel What is Divigel? Divigel is a medicine that contains the estrogen hormone estradiol, which is the same hormone made by a woman's ovaries. Divigel is a clear, colorless, smooth gel that is odorless when dry. When applied to the skin, estradiol is absorbed through the skin into the bloodstream. What is Divigel used for? Divigel 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 to 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 develop 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 estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel. Who should not use Divigel? Do not start using Divigel if you: Have unusual vaginal bleeding Currently have or have had certain cancers Estrogens may increase the chances 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 Divigel. 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 Divigel or any of its ingredients See the list of ingredients in Divigel at the end of this leaflet. Think you may be pregnant 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. About all of your medical problems 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, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. About all the medicines you take This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Divigel works. Divigel may also affect how your other medicines work. If you are going to have surgery or will be on bedrest You may need to stop using Divigel. If you are breastfeeding The hormone in Divigel can pass into your breast milk. How should I use Divigel? Divigel should be used once daily. Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you. Estrogens should be used at the lowest dose possible for your treatment and only as long as needed. 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 Divigel. How should Divigel be applied? Divigel should be applied once a day, around the same time each day Apply Divigel to clean, dry, and unbroken (without cuts or scrapes) skin. If you take a bath or shower, be sure to apply your Divigel after your skin is dry. The application site should be completely dry before dressing or swimming Apply Divigel to either your left or right upper thigh. Change between your left and right upper thigh each day to help prevent skin irritation TO APPLY: Step 1: Wash and dry your hands thoroughly. Step 2: Sit in a comfortable position. Step 3: Cut or tear the Divigel packet as shown in Figure A. Figure A Step 4: Using your thumb and index finger, squeeze the entire contents of the packet onto the skin of the upper thigh as shown in Figure B. Figure B Step 5: Gently spread the gel in a thin layer on your upper thigh over an area of about 5 by 7 inches, or two palm prints as shown in Figure C. It is not necessary to massage or rub in Divigel. Figure C Step 6: Allow the gel to dry completely before dressing. Step 7: Dispose of the empty Divigel packet in the trash. Step 8: Wash your hands with soap and water immediately after applying Divigel to remove any remaining gel and reduce the chance of transferring Divigel to other people. Important things to remember when using Divigel Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people Allow the gel to dry before dressing. Try to keep the area dry for as long as possible Do not allow others to come in contact with the area of skin where you applied the gel for at least one hour after you apply Divigel You should not allow others to apply the gel for you. However, if this is necessary, the individual should wear a disposable plastic glove to avoid direct contact with Divigel Do not apply Divigel to your face, breast, or irritated skin Never apply Divigel in or around the vagina Divigel contains alcohol. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried What should I do if I miss a dose? If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day. Do not apply Divigel more than once each day. If you accidentally spill some of the contents of a Divigel packet, do not open a new packet. Wait and apply your normal dose the next day. What should I do if someone else is exposed to Divigel? Once you have applied Divigel, it has dried, and you have washed your hands, there is little risk of transfer to another person. If someone else is exposed to Divigel by direct contact with the wet gel, that person should wash the area of contact with soap and water as soon as possible. This is especially important for men and children. The longer the gel is in contact with the skin before washing, the chance is greater that the other person will absorb some of the estrogen hormone. What should I do if I get Divigel in my eyes? If you get Divigel in your eyes, flush your eyes right away with lukewarm tap water. If you have concerns, contact your healthcare provider. What are the possible side effects of Divigel? 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 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 Divigel. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784) or to FDA at 1-800-FDA-1088. What can I do to lower my chances of a serious side effect with Divigel? Talk with your healthcare provider regularly about whether you should continue using Divigel If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman 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 Divigel. 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 higher chances of getting heart disease Ask your healthcare provider for ways to lower your chances of getting heart disease. General information about safe and effective use of Divigel Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Divigel for conditions for which it was not prescribed. Do not give Divigel to other people, even if they have the same symptoms you have. It may harm them. Keep Divigel out of the reach of children. This leaflet provides a summary of the most important information about Divigel. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Divigel that is written for health professionals. You can get more information by calling the toll free number Customer Service: 1-866-600-4799. What are the ingredients in Divigel? The active ingredient in Divigel is estradiol. The inactive ingredients are carbomer, ethanol, propylene glycol, purified water, and triethanolamine. How is Divigel Supplied? Divigel is supplied in individual foil packets, each one containing a single day's dose. Store Divigel packets 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 by Orion Corporation Orion Pharma Tengströminkatu 8 FI-20360 Turku Finland Distributed by VERTICAL PHARMACEUTICALS, LLC Bridgewater, NJ 08807 USA www.verticalpharma.com Customer Service: 1-866-600-4799 Product of Finland 2014 Vertical Pharmaceuticals, LLC 125140-08 Revised 11/2017 PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 1 mg Packet Carton NDC 68025-067-30 Divigel (estradiol gel) 0.1% 1 mg 30 packets 1 g gel provides 1 mg estradiol/packet Rx only VERTICAL PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 0.5 mg Packet Carton NDC 68025-066-30 Divigel (estradiol gel) 0.1% 0.5 mg 30 packets 0.5 g gel provides 0.5 mg estradiol/packet Rx only VERTICAL PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 0.25 mg Packet Carton NDC 68025-065-30 Divigel (estradiol gel) 0.1% 0.25 mg 30 packets 0.25 g gel provides 0.25 mg estradiol/packet Rx only VERTICAL PHARMACEUTICALS, LLC Divigel estradiol gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68025-067 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL (ESTRADIOL) ESTRADIOL 1 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOMER HOMOPOLYMER TYPE C ALCOHOL PROPYLENE GLYCOL WATER TROLAMINE Packaging # Item Code Package Description 1 NDC:68025-067-30 30 PACKET in 1 CARTON 1 1 g in 1 PACKET 2 NDC:68025-067-07 7 PACKET in 1 CARTON 2 1 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022038 10/27/2014 Divigel estradiol gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68025-066 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL (ESTRADIOL) ESTRADIOL 0.5 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOMER HOMOPOLYMER TYPE C ALCOHOL PROPYLENE GLYCOL WATER TROLAMINE Packaging # Item Code Package Description 1 NDC:68025-066-30 30 PACKET in 1 CARTON 1 0.5 g in 1 PACKET 2 NDC:68025-066-07 7 PACKET in 1 CARTON 2 0.5 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022038 10/27/2014 Divigel estradiol gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68025-065 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL (ESTRADIOL) ESTRADIOL 0.25 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOMER HOMOPOLYMER TYPE C ALCOHOL PROPYLENE GLYCOL WATER TROLAMINE Packaging # Item Code Package Description 1 NDC:68025-065-30 30 PACKET in 1 CARTON 1 0.25 g in 1 PACKET 2 NDC:68025-065-07 7 PACKET in 1 CARTON 2 0.25 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022038 10/27/2014 Labeler - Vertical Pharmaceuticals, LLC (173169017) Revised: 11/2017 Vertical Pharmaceuticals, LLC Print this page> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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