norelgestromin and ethinyl estradiol Dailymed

There are multiple options for starting the Norelgestromin and Ethinyl Estradiol transdermal system, and the woman should choose the option that is most appropriate (see Table 1): Table 1: Instructions for Administration Starting Norelgestromin and Ethinyl Estradiol Transdermal System in women with no current use of hormonal contraception The woman has two options for starting the patch and she should choose the option that is right for her: First Day Start The woman should apply her first patch during the first 24 hours of her menstrual period. If a patch is applied after the first 24 hours of menstruation, non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) is needed for the first 7 days of the first cycle only. The woman should apply a new patch each week for three weeks (21 total days). Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. No patch is worn during Week Four (the "Patch-Free Week"). Withdrawal bleeding is expected during this time. On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles. Sunday Start The woman should apply her first patch on the first Sunday after her menstrual period begins. With this option, a non-hormonal backup method of birth control, such as a condom and spermicide or diaphragm and spermicide, is needed for the first 7 days of the first cycle only. If her period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed. Switching from another contraceptive method Oral combination hormonal contraception (oral CHC) •  If the woman is switching from the pill to Norelgestromin and Ethinyl Estradiol Transdermal System, she should complete her current pill cycle and apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day she would normally start her next pill •  If she does not get her period within a week after taking the last active pill, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Norelgestromin and Ethinyl Estradiol Transdermal System for contraception. •  If the patch is applied more than a week after taking the last active pill, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use. Transdermal system •  If the woman is switching from another contraceptive transdermal system to Norelgestromin and Ethinyl Estradiol Transdermal System, she should complete the current transdermal system cycle and apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day the next transdermal system cycle would normally start. •  If she does not get her period within a week after removing the last transdermal system, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Norelgestromin and Ethinyl Estradiol Transdermal System for contraception. If Norelgestromin and Ethinyl Estradiol Transdermal System is applied more than a week after removal of the last patch, nonhormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use. Vaginal ring •  If the woman is switching from the vaginal ring to Norelgestromin and Ethinyl Estradiol Transdermal System, she should complete her current vaginal ring cycle and apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day she would normally insert her next vaginal ring. •  If she does not get her period within a week after removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Norelgestromin and Ethinyl Estradiol Transdermal System for contraception. •  If the patch is applied more than a week after removal of the last vaginal ring, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use. Injection •  If the woman is switching from an injection contraceptive to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day the next injection would normally occur. Intrauterine system (IUS) •  If the woman is switching from an intrauterine system to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day of IUS removal. If the IUS is not removed on the first day of the menstrual cycle, nonhormonal backup contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use. Implant •  If the woman is switching from an implant to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day of implant removal. Progestin-only pill •  If the woman is switching from a progestin-only pill to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day the next progestin-only pill cycle would normally start. Use after Childbirth Start contraceptive therapy with norelgestromin and ethinyl estradiol transdermal system in women who elect not to breastfeed no sooner than 4 weeks after childbirth due to increased risk of thromboembolism. If a woman begins using norelgestromin and ethinyl estradiol transdermal system postpartum, and has not yet had a period, consider the possibility of ovulation and conception occurring prior to use of norelgestromin and ethinyl estradiol transdermal system, and instruct her to use an additional method of contraception, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days. [See Warnings and Precautions (5.1) and Pregnancy (8.1).]  Use after Abortion or Miscarriage After an abortion or miscarriage that occurs in the first trimester, norelgestromin and ethinyl estradiol transdermal system may be started immediately. An additional method of contraception is not needed if norelgestromin and ethinyl estradiol transdermal system is started immediately. If use of norelgestromin and ethinyl estradiol transdermal system is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting norelgestromin and ethinyl estradiol transdermal system for the first time. In the meantime she should be advised to use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage. Start norelgestromin and ethinyl estradiol transdermal system no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. [See Contraindications (4) and Warnings and Precautions (5.1).]

CHOOSING A PLACE ON THE BODY TO PUT THE PATCH   The patch may be placed on the upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing. For example, it should not be placed under the waistband of clothing.   The patch should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch. Before applying the patch:   The woman should make sure the skin is clean and dry.   She should not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose. HOW TO APPLY THE PATCH • The woman should tear open the pouch at the edge. She should gently remove the contents of the foil pouch and discard the additional piece of film above the patch. • The woman should peel away half of the clear plastic. She should avoid touching the sticky surface with her fingers. • The woman should apply the sticky side of the patch on the skin she has cleaned and dried. She should then remove the other half of the clear plastic and attach the entire patch to her skin. • The woman should press firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. • She should run her fingers over the entire surface area to smooth out any "wrinkles" around the outer edges of the patch.   The woman should check her patch every day to make sure all edges are sticking correctly. WHEN TO CHANGE THE NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM PATCH   The patch works for 7 days (1 week). The woman should apply a new patch on the same day each week (her Patch Change Day) for 3 weeks in a row. She must make sure she has removed her old patch prior to applying the new patch.   During Week 4, she DOES NOT wear a patch. She must make sure she removes her old patch. (Her period should begin during this week.)   Following Week 4, she repeats the cycle of three weekly applications followed by a patch-free week. WHAT IF THE PATCH BECOMES LOOSE OR FALLS OFF? The patch must stick securely to the skin to work properly. If the norelgestromin and ethinyl estradiol transdermal system patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. The woman should not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it. If a patch edge lifts up:   The woman should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. She should run her fingers over the entire surface area to smooth out any "wrinkles" around the edges of the patch.   If her patch does not stick completely, she should remove it and apply a replacement patch.   She should not tape or wrap the patch to her skin or reapply a patch that is partially adhered to clothing. If the patch has been off or partially off:   For less than 1 Day , she should try to reapply it. If the patch does not adhere completely, she should apply a new patch immediately. (No backup contraception is needed and her Patch Change Day will stay the same).   For more than 1 Day or if she is not sure for how long , she may not be protected from pregnancy. To reduce this risk, she should apply a new patch and start a new 4-week cycle. She will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom and spermicide or diaphragm and spermicide) for the first week of her new cycle. IF THE WOMAN FORGETS TO CHANGE HER PATCH ● at the start of any patch cycle (Week 1/Day 1): SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should apply the first patch of her new cycle as soon as she remembers. There is now a new "Patch Change Day" and a new "Day 1." The woman must use back-up contraception, such as a condom and spermicide or diaphragm and spermicide, for the first week of the new cycle. ● in the middle of the patch cycle (Week 2/Day 8 or Week 3/Day 15), ○ for 1 or 2 days (up to 48 hours), she should apply a new patch immediately. The next patch should be applied on the usual "Patch Change Day." No back-up contraception is needed. ○ for more than 2 days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should stop the current contraceptive cycle and start a new 4-week cycle immediately by putting on a new patch. There is now a new "Patch Change Day" and a new "Day 1." The woman must use back-up contraception for 1 week. ● at the end of the patch cycle (Week 4/Day 22), ○ If the woman forgets to remove her patch, she should take it off as soon as she remembers. The next cycle should be started on the usual "Patch Change Day," which is the day after Day 28. No back-up contraception is needed. Under no circumstances should there be more than a 7-day patch-free interval between cycles. If there are more than 7 patch-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY and back-up contraception, such as a condom and spermicide or diaphragm and spermicide, must be used for 7 days. As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended drug-free period. If she has had intercourse during such an extended patch-free interval, consider the possibility of pregnancy. Change Day Adjustment If the woman wishes to change her Patch Change Day, she should complete her current cycle, removing the third norelgestromin and ethinyl estradiol transdermal system patch on the correct day. During the patch-free week, she may select an earlier Patch Day Change by applying a new norelgestromin and ethinyl estradiol transdermal system patch on the desired day. In no case should there be more than 7 consecutive patch-free days. Breakthrough Bleeding or Spotting In the event of unscheduled or breakthrough bleeding or spotting (bleeding that occurs on the days that norelgestromin and ethinyl estradiol transdermal system is worn), treatment should be continued. If unscheduled bleeding persists longer than a few cycles, consider causes other than norelgestromin and ethinyl estradiol transdermal system. If the woman does not have scheduled or withdrawal bleeding (bleeding that should occur during the patch-free week), she should resume treatment on the next scheduled Change Day. If norelgestromin and ethinyl estradiol transdermal system has been used correctly, the absence of withdrawal bleeding is not necessarily an indication of pregnancy. Nevertheless, consider the possibility of pregnancy, especially if absence of withdrawal bleeding occurs in 2 consecutive cycles. Discontinue norelgestromin and ethinyl estradiol transdermal system if pregnancy is confirmed. In Case of Skin Irritation If patch use results in uncomfortable irritation, the patch may be removed and a new patch may be applied to a different location until the next Change Day. Only one patch should be worn at a time. Additional Instructions for Dosing Unscheduled bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing hormonal contraceptives. In case of breakthrough bleeding, as in all cases of irregular bleeding from the vagina, consider nonfunctional causes. In case of undiagnosed persistent or recurrent abnormal bleeding from the vagina, take adequate diagnostic measures to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another method of contraception may solve the problem. Use of Hormonal Contraceptives in the Event of a Missed Menstrual Period If the woman has not adhered to the prescribed schedule, consider the possibility of pregnancy at the time of the first missed period. Discontinue use of norelgestromin and ethinyl estradiol transdermal system if pregnancy is confirmed. If the woman has adhered to the prescribed regimen and misses one period, she should continue using her contraceptive patches. However, if she has adhered to the prescribed regimen, misses one period and has symptoms associated with pregnancy, rule out pregnancy. Discontinue norelgestromin and ethinyl estradiol transdermal system use if pregnancy is confirmed. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue norelgestromin and ethinyl estradiol transdermal system use if pregnancy is confirmed.

  Stop norelgestromin and ethinyl estradiol transdermal system if an arterial or venous thromboembolic event (VTE) occurs.   Stop norelgestromin and ethinyl estradiol transdermal system if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.   If feasible, stop norelgestromin and ethinyl estradiol transdermal system at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Discontinue use of norelgestromin and ethinyl estradiol transdermal system during prolonged immobilization and resume treatment based on clinical judgment.   Start norelgestromin and ethinyl estradiol transdermal system no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.   Before starting norelgestromin and ethinyl estradiol transdermal system, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy [see Contraindications (4)]. Arterial Events The use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity. Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women over 35 years of age who smoke [see Contraindications (4)]. Cigarette smoking increases the risk of serious cardiovascular events from CHC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Venous Events The use of CHCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs. The risk of VTE may be greater with norelgestromin and ethinyl estradiol transdermal system in women with a BMI ≥ 30 kg/m2 compared to women with a lower BMI [see Contraindications (4)]. While the increased risk of VTE associated with use of CHCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The frequency of VTE in women using CHCs has been estimated to be 3 to 12 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. This initial higher risk declines during the first year, but users of CHCs remain at an increased risk of VTE compared to non-users of CHCs. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. The risk of thromboembolic disease due to CHCs gradually disappears after CHC use is discontinued. Figure 1 shows the risk of developing a VTE for women who are not pregnant and do not use CHCs, for women who use CHCs with a range of doses and routes of administration, for pregnant women, and for women in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use CHCs are followed for one year, between 1 and 5 of these women will develop a VTE. Figure 1 Likelihood of Developing a VTE Within One Year Among Pregnant and Non-Pregnant Women

Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease. A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis.

Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease. A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis.

Unscheduled Bleeding and Spotting Unscheduled (breakthrough) bleeding and spotting sometimes occur in women using norelgestromin and ethinyl estradiol transdermal system. Consider non-hormonal causes and take adequate diagnostic measures to rule out malignancy, other pathology, or pregnancy in the event of unscheduled bleeding, as in the case of any abnormal vaginal bleeding. If pathology and pregnancy have been excluded, time or a change to another contraceptive product may resolve the bleeding. In the clinical trials, most women started their scheduled (withdrawal) bleeding on the fourth day of the drug-free interval, and the median duration of withdrawal bleeding was 5 to 6 days. On average, 26% of women per cycle had 7 or more total days of bleeding and/or spotting (this includes both scheduled and unscheduled bleeding and/or spotting). Three clinical studies of the efficacy of norelgestromin and ethinyl estradiol transdermal system in preventing pregnancy assessed scheduled and unscheduled bleeding [see Clinical Studies (14)] in 3,330 women who completed 22,155 cycles of exposure. A total of 36 (1.1%) of the women discontinued norelgestromin and ethinyl estradiol transdermal system at least in part, due to bleeding or spotting. Table 2 summarizes the proportion of subjects who experienced unscheduled (breakthrough) bleeding/spotting by treatment cycle. Table 2: Unscheduled (Breakthrough) Bleeding/Spotting (Subjects Evaluable for Efficacy) Treatment Cycle Pooled data from 3 studies N=3319 n %* Cycle 1 2994 18.2 Cycle 2 2743 11.9 Cycle 3 2699 11.6 Cycle 4 2541 10.1 Cycle 5 2532 9.2 Cycle 6 2494 8.3 Cycle 7 698 8.3 Cycle 8 692 8.7 Cycle 9 654 8.6 Cycle 10 621 8.7 Cycle 11 631 8.9 Cycle 12 617 6.3 Cycle 13 611 8.0 *Percentage of subjects with breakthrough bleeding/spotting events. Amenorrhea and Oligomenorrhea In the event of amenorrhea, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one patch or started the patch on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Some women may encounter amenorrhea or oligomenorrhea after discontinuation of hormonal contraceptive use, especially when such a condition was pre-existent.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue norelgestromin and ethinyl estradiol transdermal system use if pregnancy is confirmed.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue norelgestromin and ethinyl estradiol transdermal system use if pregnancy is confirmed. Administration of CHCs should not be used as a test for pregnancy [see Use in Specific Populations (8.1)].

There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy.

There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy. The administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion.

The effects of norelgestromin and ethinyl estradiol transdermal system in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.

The effects of norelgestromin and ethinyl estradiol transdermal system in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.

Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with a BMI ≥ 30 kg/m2 because of the potential increased risk of VTE [see Contraindications (4) and Warnings and Precautions (5.1)]. Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs. or more [see Clinical Studies (14)].

Counsel patients about the following information:   Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive use, and that women who are over 35 years old and smoke should not use combined hormonal contraceptives.   The use of CHCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of CHCs. The risk of VTE in women using CHCs is 3 to 12 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to CHCs gradually disappears after use is discontinued.   Norelgestromin and ethinyl estradiol transdermal system does not protect against HIV infection (AIDS) and other sexually transmitted infections.   The Warnings and Precautions associated with combined hormonal contraceptives.   Norelgestromin and ethinyl estradiol transdermal system is not to be used during pregnancy; if pregnancy occurs during use of norelgestromin and ethinyl estradiol transdermal system, instruct the patient to stop further use.   Apply a single patch the same day every week (Weeks 1 through 3). Instruct patients what to do in the event a patch is missed. See "WHAT IF I FORGET TO CHANGE MY PATCH?" section in FDA-Approved Patient Labeling.   Use a back-up or alternative method of contraception when enzyme inducers are used with norelgestromin and ethinyl estradiol transdermal system.   Combined hormonal contraceptives may reduce breast milk production; this is less likely to occur if breastfeeding is well established.   Women who start combined hormonal contraceptives postpartum, and who have not yet had a period, should use an additional method of contraception until they have used a patch for 7 consecutive days.   Amenorrhea may occur. Consider pregnancy in the event of amenorrhea. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles, amenorrhea in one cycle if the woman has not adhered to the dosing schedule, or if associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness.   If the norelgestromin and ethinyl estradiol transdermal system patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. ○          A patch should not be re-applied if it is no longer sticky, becomes stuck to itself or another surface, has other material stuck to it, or has become loose or fallen off before. If a patch cannot be re-applied, a new patch should be applied immediately. Supplemental adhesives or wraps should not be used. ○          A woman may not be protected from pregnancy if a patch is partially or completely detached for ≥ 24 hours (or if the woman is not sure how long the patch has been detached). She should start a new cycle immediately by applying a new patch. Back-up contraception, such as a condom and spermicide or diaphragm and spermicide, must be used for the first week of the new cycle. The brands uled are trademarks of their respective owners. Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 06/23