GWYN LO is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Transdermal System: 220 mcg/day norelgestromin (NGMN) and 20 mcg/day ethinyl estradiol (EE), 14 cm² tan colored product with name and strength printed in brown ink on the backing membrane.

GWYN LO is contraindicated in females who are known to have or develop the following conditions:

•

A high risk of arterial or venous thromboembolic events. Examples include women who:

o

Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]

o

Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]

o

Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]

o

Have cerebrovascular disease [see Warnings and Precautions (5.1)]

o

Have coronary artery disease [see Warnings and Precautions (5.1)]

o

Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]

o

Have uncontrolled hypertension [see Warnings and Precautions (5.4)]

o

Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]

o

Have headaches with focal neurological symptoms or have migraine headaches with aura or women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]

•

Body Mass Index ≥ 30 kg/m2 [see Boxed Warning, Warnings and Precautions (5.1), and Use in Specific Populations (8.7)]

•

Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)]

•

Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]

•

Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.10)]

•

Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, due to the potential for alanine aminotransferase (ALT) elevations [see Warnings and Precautions (5.3)]

The following serious adverse reactions with the use of combination hormonal contraceptives, including GWYN LO, are discussed elsewhere in the labeling:

•

Serious cardiovascular events including venous and arterial thromboembolism [see Boxed Warning, Contraindications (4), Warnings and Precautions (5.1)]

•

Liver Disease [see Warnings and Precautions (5.2)]

Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in women. In case of suspected overdose, remove all GWYN LO transdermal systems and provide symptomatic treatment.

GWYN LO (norelgestromin and ethinyl estradiol transdermal system) contains 4.86 mg norelgestromin, USP, a progestin, and 0.264 mg ethinyl estradiol, USP, an estrogen.

GWYN LO is a transdermal system (TDS) designed to provide consistent delivery of norelgestromin and ethinyl estradiol over a 7-day wear period. Based on residual drug analysis from TDS used in clinical studies, GWYN LO is expressed as 220 mcg/day norelgestromin and 20 mcg/day ethinyl estradiol. GWYN LO is a thin, matrix-type transdermal system consisting of three layers. The backing layer is printed with brown ink and is composed of a tan flexible film consisting of a pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains the norelgestromin and ethinyl estradiol and the following inactive ingredients crospovidone, dipropylene glycol, mineral oil, nonwoven polyester fabric, oleyl alcohol, and polyisobutylene adhesive. The third layer is a transparent release coated polyester liner, which protects the adhesive layer during storage and is removed just prior to application.

GWYN LO transdermal systems are packaged with additional pieces of oversized protective film above and below the system within each pouch. These pieces of oversized protective film are removed and discarded at the time of use.

The efficacy of GWYN LO was evaluated in Study 1, a Phase 3, open label, single arm, multicenter trial in the United States, and Canada (NCT05139121) of one-year duration that enrolled 1,320 women, ranging in age between 16 and 54 years, who were healthy and sexually active with regular menstrual cycles.

The primary efficacy analysis population included 983 women between the ages of 16 and 35 years with BMI < 30 kg/m2, who completed 9,105 evaluable cycles with GWYN LO, where no back-up contraception was used, and sexual intercourse occurred. The mean age was 26.4 years (range: 16 to 35) with an average baseline BMI of 24 kg/m2 (range: 15 to 30 kg/m2). The racial/ethnic distribution was Whites (68.9%), Black/African Americans (18.7%), Asians (7.5%), American Indians/Alaskan Natives (1.1%), Native Hawaiian/Pacific or Other Pacific Islander (0.3%), and Other (3.5%); 45.5% were Hispanics.

The primary efficacy endpoint was the Pearl Index (PI), defined as the number of pregnancies per 100-woman years of exposure. The overall PI was 4.14 (95% CI: 2.77 to 5.95). There were no differences in efficacy by BMI Category as shown in Table 6 below.

Adhesion

Based on data from four studies investigating various application sites and conditions (e.g., sauna, whirlpool and treadmill), a total of 323 out of 342 (94.44%) applied systems had 75% or greater surface area adhesion at all timepoints evaluated (every 24 hours) throughout the 7-day wear period.

In Study 1, 1.3% of all transdermal systems worn during the year-long trial (39,790 transdermal systems) fully detached. No notable differences in subject reported adhesion score were found based on application sites.

Advise the woman to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Cigarette Smoking

Advise the woman that cigarette smoking increases the risk of serious cardiovascular events from CHC use. Women who are over 35 years old and smoke should not use GWYN LO [see Boxed Warning and Warnings and Precautions (5.1)].

Venous Thromboembolism

Advise the woman that there is an increased risk of VTE compared to non-users of CHCs which is greatest after initially starting a CHC or restarting (following a 4-week or greater interruption in intake) the same or a different CHC [see Warnings and Precautions (5.1)].

Use During Pregnancy

Instruct the woman to stop GWYN LO if pregnancy is confirmed during treatment [see Use in Specific Populations (8.1)].

Sexually Transmitted Infections

Advise the woman that GWYN LO does not protect against HIV infection and other sexually transmitted infections.

Missed Dosing Instructions

Apply one GWYN LO TDS weekly for 3 weeks followed by one TDS-free week. Instruct women what to do in the event the TDS change is missed. See the FDA-approved patient labeling (Instructions for Use) [see Dosage and Administration (2.4)].

Need for Additional Contraception

Advise postpartum women who have not yet had a period when they start GWYN LO to use an additional method of contraception until they have used GWYN LO for one week [see Dosage and Administration (2.2)].

Advise the woman to use a back-up or alternative method of contraception when enzyme inducers are used with GWYN LO [see Drug Interactions (7.1)].

Lactation

GWYN LO may reduce breast milk production. This is less likely to occur if breastfeeding is well established. When possible, advise nursing women to use other methods of contraception until they have discontinued breastfeeding [see Use in Specific Populations (8.2)].

Amenorrhea and Possible Symptoms of Pregnancy

Amenorrhea may occur. Advise the woman to contact a healthcare provider in the event of amenorrhea in two or more consecutive cycles or in case of symptoms of pregnancy such as morning sickness or unusual breast tenderness [see Warnings and Precautions (5.8)].

Avoidance of GWYN LO Detachment

Advise women not to use lotions, creams, oils, powders, or make-up at the TDS site and to check the GWYN LO TDS for partial or complete detachment not only daily but also after any water exposure (for example, bathing or showering) to make sure all edges are sticking correctly [see Dosage and Administration (2.4)].

Keep GWYN LO and all medicines out of reach of children and pets.

Distributed by:
Viatris Specialty LLC
Morgantown, WV 26505 U.S.A.

© 2026 Viatris Inc.

Gwyn Lo is a trademark of Mylan Pharmaceuticals Inc., a Viatris Company.

VSL:NEETSLO222:R1

GWYN LOTM [GWEN-low] (norelgestromin and ethinyl estradiol transdermal system)

What is the most important information I should know about GWYN LO? • Do not use GWYN LO if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from combination hormonal contraceptives (CHCs), including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. • Do not use GWYN LO if your Body Mass Index (BMI) is 30 kg/m2 or more. Women with a BMI of 30 kg/m2 or more who use GWYN LO may be at a higher risk for developing blood clots compared to women with a BMI lower than 30 kg/m2.

Hormonal birth control methods help to lower the chances of becoming pregnant when taken as directed. GWYN LO does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

What is GWYN LO? GWYN LO is: • a birth control patch for women with a BMI less than 30 kg/m2 who can become pregnant. It contains two female hormones, a progestin called norelgestromin, and an estrogen called ethinyl estradiol.

How well does GWYN LO work? Your chance of getting pregnant depends on how well you follow the directions for using GWYN LO. The better you follow the directions, the less chance you have of getting pregnant.   In a clinical study, 4 out of 100 women got pregnant in one year that they used GWYN LO.   For GWYN LO to be most effective, you must use GWYN LO exactly as your healthcare provider tells you to. Each patch must be fully attached to the skin during the 7 days in order for it to work the best.   The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Do not use GWYN LO if you: • smoke and are over 35 years old. • have or have had blood clots in your arms, legs, eyes or lungs. • have had a stroke. • have had a heart attack. • have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart. • have a problem that makes your blood clot more than normal that you were born with (inherited) or that has happened for other reasons such as medicines, surgery or injuries (acquired). • have high blood pressure that is not controlled. • have diabetes with kidney, eye, nerve, or blood vessel damage. • have had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over age 35. • have a BMI of 30 or more. • have liver problems including liver tumors, hepatitis, cirrhosis, or liver disease. • have unexplained vaginal bleeding. • have or have had breast cancer or any cancer that is sensitive to female hormones. • take any Hepatitis C drug combination-containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, or with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir. This may increase levels of the liver enzyme called alanine aminotransferase (ALT) in the blood. GWYN LO may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes). Tell your healthcare provider if you have ever had any of the above conditions. Your healthcare provider may recommend another method of birth control.

Before using GWYN LO, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or think you are pregnant. GWYN LO is not for pregnant women. If you think you are pregnant, you should have a pregnancy test and know the results. Do not use GWYN LO if the test is positive and talk to your healthcare provider. • are scheduled for surgery. GWYN LO may increase your risk of blood clots after surgery. You should stop using your GWYN LO patch at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery. • have or have had gallbladder problems including yellowing of the skin or eyes during pregnancy. • have high cholesterol that is not controlled. • have or have had depression. • have a history of hereditary angioedema. • have had dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). • are breastfeeding or plan to breastfeed. CHC may decrease the amount of milk you make. A small amount of hormones from the GWYN LO patch may pass into your breast milk. Talk with your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.   GWYN LO may affect the way other medicines work, and other medicines may affect how well GWYN LO works. • Some medicines and herbal products may make GWYN LO less effective or cause breakthrough bleeding, including, but not limited to: o certain anti-seizure medicines (such as barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, or topiramate). o medicine to treat chemotherapy-induced nausea and vomiting (aprepitant). o medicine to treat high blood pressure in the vessels of the lung (bosentan). o a certain medicine used to treat fungal infections (griseofulvin). o certain combinations of HIV medicines (nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir). o certain non-nucleoside reverse transcriptase inhibitors (such as nevirapine and efavirenz). o rifampin and rifabutin. o certain hepatitis C (HCV) medicines (such as boceprevir or telaprevir). o St. John’s wort. Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make GWYN LO less effective and for 28 days after stopping the medicine. • Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together, including: o acetaminophen for pain relief. o ascorbic acid. o certain medicines used to treat fungal infections (itraconazole, ketoconazole, voriconazole, and fluconazole). o certain HIV medicines (atazanavir/ritonavir, indinavir). o non-nucleoside reverse transcriptase inhibitors (such as etravirine). o medicines to lower cholesterol (such as atorvastatin and rosuvastatin). • GWYN LO may affect the way that lamotrigine, a medicine used to treat seizures, works and may increase the risk of seizures. Your healthcare provider may need to adjust the dose of lamotrigine while you are on GWYN LO. • If you are scheduled for any laboratory tests, tell your healthcare provider that you are using GWYN LO. Certain blood tests may be affected by CHC methods. • Women on thyroid replacement therapy may need increased doses of thyroid replacement medicine or corticosteroid replacement medicine. Ask your healthcare provider if you are not sure if you take any of the medicines listed above.   Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Talk to your healthcare provider before you start taking a new medicine.

How should I use GWYN LO? • For detailed instructions, see the step-by-step instructions for using GWYN LO in the Instructions for Use. • Use GWYN LO exactly as your healthcare provider tells you to use it. • Wear 1 GWYN LO patch at a time. Make sure you remove your old GWYN LO patch before applying your new GWYN LO patch. • Check your patch every day and after any water exposure (such as bathing or showering) to make sure all edges are sticking correctly. • Do not cut or alter the patch in any way. If the patch is cut, damaged or changed in any way, it may be less effective. • Do not skip using any GWYN LO patches, even if you do not have sex often. • GWYN LO is applied in a 4-week cycle. o Apply your GWYN LO patch 1 time each week for 3 weeks (21 total days). o Apply each new GWYN LO patch on the same day of the week. This day will be your “Patch Change Day.” For example, if you apply your first GWYN LO patch on a Monday, all of your GWYN LO patches should be applied on a Monday. o Do not apply your GWYN LO patch during Week 4. Make sure you remove your old GWYN LO patch. This is your patch-free week. Your menstrual period should start during your patch-free week. o Begin a new 4-week cycle by applying a new GWYN LO patch on the day after Week 4 ends. Repeat the cycle of 3 weekly applications followed by a patch-free week. • Your GWYN LO patch should never be off for more than 7 days in a row. If your GWYN LO patch is off for more than 7 days in a row and you have sex during this time, you could become pregnant. • If you miss a period, you might be pregnant. Some women miss their periods or have light periods on hormonal birth control methods even when they are not pregnant. Call your healthcare provider if you miss 1 period and have not used your GWYN LO patch every day or you miss 2 periods in a row.

What should I avoid while taking GWYN LO? • Smoking • The following can cause the patch to not stick the right way making GWYN LO less effective: o Avoid using makeup, creams, lotions, oils, powders or any other products on the skin area where you put or plan to put the patch. o Contact with water for long periods of time (30 minutes or more). Talk with your healthcare provider about the best method of birth control if you are a swimmer or you often come in contact with water for 30 minutes or more. • Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while using GWYN LO. Use sunscreen if you have to be in the sunlight

What are the possible side effects of GWYN LO? GWYN LO may cause serious side effects, including:    • See “What is the most important information I should know about GWYN LO?”   • blood clots. Like pregnancy, hormonal birth control may increase the risk of serious blood clots (see following graph), especially in women who have other risk factors such as smoking, high blood pressure, high levels of fat in the blood, diabetes, obesity, a family history of blood clots, or are older than 35 years old. This increased risk is highest when you first start using hormonal birth control and when you restart the same or different hormonal birth control after not using it for a month or more. Some studies have reported that women who use norelgestromin and ethinyl estradiol transdermal system have a higher risk of getting a blood clot. Talk with your healthcare provider about your risk of getting a blood clot before using GWYN LO or deciding which type of birth control is right for you.   It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the: o legs (deep vein thrombosis) o lungs (pulmonary embolus) o eyes (loss of eyesight) o heart (heart attack) o brain (stroke) To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use hormonal birth control are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use hormonal birth control, for women who use hormonal birth control, for pregnant women, and for women in the first 12 weeks after delivering a baby.   Likelihood of Developing a Serious Blood Clot (Venous Thromboembolism [VTE]) Call your healthcare provider right away if you have: o leg pain that will not go away o sudden shortness of breath o sudden changes to your vision or blindness o severe pain or pressure in your chest o sudden, severe headache unlike your usual headaches o weakness or numbness in an arm or leg o trouble speaking   • liver problems, including liver tumors. Stop using GWYN LO and tell your healthcare provider right away if you have yellowing of your skin or eyes (jaundice). • high blood pressure. Your healthcare provider will check your blood pressure and may stop you from using GWYN LO if your blood pressure rises. • gallbladder problems or worsening of a gallbladder problem you already have. You may have an increased risk of gallbladder problems with the use of GWYN LO especially if you have had gallbladder problems before or gallbladder problems when you were pregnant. • headaches. Headaches can be a common but serious side effect. Tell your healthcare provider if you have new headaches that keep coming back, that do not go away, or are severe. Also tell your healthcare provider if your migraine headaches happen more often or are more severe than normal. Your healthcare provider may stop you from using GWYN LO. • irregular or unusual vaginal bleeding and spotting between your menstrual periods or absence of menstrual periods (amenorrhea). This can happen especially during the first 3 months of using GWYN LO. You also may have no bleeding at all. Tell your healthcare provider if you miss 2 or more menstrual cycles. After you stop using GWYN LO, your periods may not happen as often or you may have no bleeding at all, especially if you had these types of menstrual cycles before taking GWYN LO. • depression. • swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider or get emergency medical care right away if you have a swollen face, lips, mouth, tongue or throat as this may lead to difficulty swallowing or breathing. Your risk of having angioedema is higher if you have a history of angioedema. • dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Your risk of getting chloasma with the use of GWYN LO is higher if you had chloasma during pregnancy. The most common side effects of GWYN LO include: • skin irritation, redness, itching or rash at the patch application site • bleeding between periods and heavy periods • nausea Tell your healthcare provider about any side effects that bother you or that do not go away.   These are not all the possible side effects of GWYN LO.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store GWYN LO? • Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not store GWYN LO in the refrigerator or freezer. • Store GWYN LO in the original unopened pouch it comes in. Apply GWYN LO right away after taking it out from the pouch. • Used GWYN LO patches still contain some active hormones. To throw away the GWYN LO patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Do not flush used GWYN LO patches down the toilet. Return unused, unneeded, or expired patches to your pharmacist. Keep GWYN LO and all medicines out of the reach of children and pets.

General information about the safe and effective use of GWYN LO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not give GWYN LO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about GWYN LO that is written for health professionals.

Does hormonal birth control cause cancer? It is not known if hormonal birth control causes breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use. If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones. If you have questions regarding your risk of breast cancer, contact your healthcare provider.   Women who use hormonal birth control methods may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.   What should I know about my period when using GWYN LO? When you use GWYN LO you may have bleeding and spotting between periods, called unplanned bleeding. Unplanned bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Unplanned bleeding occurs most often during the first few months of GWYN LO use but may also occur after you have been using the patch for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using the patch on schedule. If the unplanned bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider.   What if I miss my scheduled period when using GWYN LO? Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month when you did not use all of your patches correctly, or you have symptoms associated with pregnancy, such as morning sickness or unusual breast tenderness, call your healthcare provider because you may be pregnant. Stop taking GWYN LO if you are pregnant.   What if I want to become pregnant? You may stop using GWYN LO whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop using the patch.

What are the ingredients in GWYN LO? Active ingredient: norelgestromin and ethinyl estradiol Inactive ingredients: crospovidone, dipropylene glycol, mineral oil, nonwoven polyester fabric, oleyl alcohol, polyethylene/polyester film, polyisobutylene adhesive and release coated polyester liner. Each patch is printed with brown ink.

Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A.   © 2026 Viatris Inc.   Gwyn Lo is a trademark of Mylan Pharmaceuticals Inc., a Viatris Company. For more information, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX).   VSL:PL:NEETSLO:R2

This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 7/2026

GWYN LO™ [GWEN-low]
(norelgestromin and ethinyl estradiol transdermal system)

This Instructions for Use contains information on how to use GWYN LO transdermal system (TDS) (also called a patch).

Important Information You Need to Know Before Using GWYN LO

•

Each patch is individually sealed in a pouch. Do not remove the patch from the pouch until you are ready to apply it.

•

GWYN LO is for skin use only.

•

Do not share your GWYN LO patch with any other person.

•

Do not cut, damage or alter your GWYN LO patch in any way.

•

Wear the patch for 7 Days (1 week) and then apply a new patch. If the patch is cut, damaged or changed in any way, it may be less effective.

•

Apply a new patch on the same day each week (Patch Change Day) for 3 weeks (Weeks 1 to 3).

•

Remove the old GWYN LO patch before applying a new one.

•

During Week 4, do not wear a patch.

•

After Week 4, repeat the cycle of 3 weeks of applying a patch followed by a patch free week.

•

The patch must stick securely to your skin to work properly.

•

Do 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.

•

Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing.

•

If you are not sure how to use your patch:

o

Use a back-up contraception method such as a condom and spermicide or diaphragm and spermicide anytime you have sex. Make sure to have one of these non-hormonal contraception methods ready at all times.

Preparing to use GWYN LO

•

If you are not currently using hormonal birth control, you have 2 ways to begin using your GWYN LO patch. Choose the way that is best for you:

o

Day 1 Start: Apply your first GWYN LO patch during the first 24 hours of your menstrual period. Your “Patch Change Day” will be on this day every week. If you start after the first 24 hours of your menstrual period, non-hormonal back up birth control (such as condoms and spermicide, or diaphragm and spermicide) should be used in addition to the patch for the first 7 days of your first patch cycle.

o

Sunday Start: Apply your first GWYN LO patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first GWYN LO patch that day, and no back-up birth control is needed.

•

If you are changing from oral hormone birth control pills, a vaginal contraceptive ring or another contraceptive patch to the GWYN LO patch:

o

Complete your current oral hormone birth control pill cycle, vaginal ring cycle or contraceptive transdermal patch cycle. Apply your first GWYN LO patch on the day you would normally start your next oral hormone birth control pill, patch or insert your next vaginal ring.

o

If you do not get your period within 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or contraceptive transdermal patch, check with your healthcare provider to make sure you are not pregnant. You may still go ahead and start GWYN LO patch for contraception.

o

If you apply your GWYN LO patch more than 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or contraceptive transdermal patch, use a non-hormonal contraceptive method, such as a condom and spermicide or diaphragm and spermicide with the GWYN LO patch for the first 7 days of patch use.

•

If you are using GWYN LO after childbirth:

o

If you are not breastfeeding, wait 4 weeks before using GWYN LO and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting GWYN LO.

•

If you start using GWYN LO after a miscarriage or abortion:

o

You may start GWYN LO right away after a miscarriage or abortion that occurs in the first 12 weeks (first trimester) of pregnancy. You do not need to use another contraceptive method.

o

If you do not start GWYN LO within 5 days after a first trimester miscarriage or abortion, use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, while you wait for your period to start. You have 2 ways to begin using your GWYN LO patch. Choose the way that is best for you:

▪

Day 1 Start: Apply your first GWYN LO patch during the first 24 hours of your menstrual period.

▪

Sunday Start: Apply your first GWYN LO patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first GWYN LO patch that day, and no back-up birth control is needed.

•

If you are starting GWYN LO after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using GWYN LO and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your miscarriage or abortion, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting GWYN LO.

How to Apply GWYN LO

Step 1. Choose a place on your body to apply your GWYN LO patch

Figure A

•

Apply the patch on your upper outer arm, abdomen, buttock or back in a place where it will not be rubbed by tight clothing. See Figure A. Avoid the waistline or straps because clothing and belts may cause your patch to be rubbed off.

•

Do not apply the patch to your breasts, on cut or irritated skin, or on the same place as the previous system, but you may use the same body part (upper outer arms, abdomen, buttock, or back).

•

Before applying the patch:

o

Clean and dry the skin.

•

Do not apply any powder, cream, oil, or lotion to the skin.

Step 2. Apply your GWYN LO patch

Figure B	• Tear open the pouch at the top edge and one side edge. Peel open the foil pouch. See Figure B. Gently remove the contents of the foil pouch and throw away (discard) the additional pieces of film above and below the patch, being careful not to separate the patch from the clear plastic cover.
Figure C	• Hold the patch with the clear plastic facing you. Peel away one piece of the clear plastic. Throw away (discard) the clear plastic. Avoid touching the sticky surface with your fingers. See Figure C.
Figure D	• Apply the sticky side of the patch to clean, dry skin. Remove the other piece of the clear plastic and apply the entire patch to your skin. See Figure D. Throw away (discard) the clear plastic.
Figure E	• Press firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. • Run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the patch. See Figure E. • Check your patch every day and after any water exposure (such as bathing or showering) to make sure all edges are sticking correctly.

Step 3. Removing your GWYN LO patch

•

Remove your patch after 7 days on your Patch Change Day.

Disposing of GWYN LO

•

To throw away the patch, fold the sticky sides of the patch together, place it in a sturdy child-proof container, and place the container in the trash.

•

Used patches should not be flushed down the toilet.

•

For more information on how to safely throw away medicines, see www.fda.gov/drugdisposal.

Storing GWYN LO

•

Store at 68°F to 77°F (20°C to 25°C). Do not store in the refrigerator or freezer.

•

Store patches in their protective pouches.

•

Apply right away upon removal from the protective pouch.

•

Keep GWYN LO and all medicines out of reach of children and pets.

Additional Information:

•

If your patch edge lifts up:

o

Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the patch.

o

If your patch does not stick completely, remove it and apply a new patch.

•

If your patch has been off or partially off:

o

For less than 1 Day, try to reapply it. If the patch does not stick completely, apply a new patch right away. No back-up contraception is needed and your “Patch Change Day” will stay the same.

o

For more than 1 Day or if you are not sure for how long, you could become pregnant. To reduce this chance, apply a new patch and start a new 4-week cycle. You will now have a new “Patch Change Day.” Use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first week of your new 4-week patch cycle.

o

Only one patch should be worn at a time.

•

If you want to move your “Patch Change Day” to a different day of the week, finish your current cycle. Remove your third patch on the correct day.

o

During week 4, the “Patch Free Week” (Day 22 through Day 28), you may choose an earlier “Patch Change Day” by applying a new patch on the day you prefer. You now have a new Day 1 and a new “Patch Change Day.”

•

If your patch becomes uncomfortable or your application site is red, painful or swollen, change your patch. Remove your patch and apply a new patch to a new location until your next “Patch Change Day.”

•

If you forget to change or remove your patch:

o

At the start of any patch cycle (Week 1, Day 1):

▪

You could become pregnant. You must use a back-up contraception method for 7 days. Apply the first patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1.

o

In the middle of your patch cycle (Week 2 or Week 3):

▪

If you forget to change your patch for 1 or 2 days, apply a new patch as soon as you remember. Apply your next patch on your normal “Patch Change Day.” No back-up contraception method is needed.

▪

If you forget to change your patch for more than 2 days, you could become pregnant. Start a new 4-week cycle as soon as you remember by putting on a new patch. You now have a different “Patch Change Day” and a new Day 1. You must use a back-up contraception method for the first 7 days of your new cycle.

o

At the end of your patch cycle (Week 4):

▪

If you forget to remove your patch, take it off as soon as you remember. Start your next cycle on your normal “Patch Change Day,” the day after Day 28. No back-up contraception method is needed.

•

If you forget to apply your patch at the start of your next patch cycle, you could become pregnant. Apply the first patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1. Use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first 7 days of your new 4-week patch cycle.

•

If you have trouble remembering to change your patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception.

•

If you find yourself in need of an additional patch because you needed to replace a patch, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX).

Distributed by:
Viatris Specialty LLC
Morgantown, WV 26505 U.S.A.

© 2026 Viatris Inc.

Gwyn Lo is a trademark of Mylan Pharmaceuticals Inc., a Viatris Company.

VSL:IFU:NEETSLO:R2

This Instructions for Use has been approved by the U.S. FDA and Drug Administration.

Issued: 7/2026

NDC 49502-627-62

Contents: 3 Transdermal Systems | Rx only

Gwyn Lo™
(norelgestromin and ethinyl estradiol
transdermal system) 220 mcg/20 mcg per day

Each 14 cm2 system contains 4.86 mg norelgestromin, USP and 0.264 mg ethinyl
estradiol, USP. The inactive components are crospovidone, dipropylene glycol,
mineral oil, nonwoven polyester fabric, oleyl alcohol, polyethylene/polyester film,
polyisobutylene adhesive and release coated polyester liner. Each patch is printed
with brown ink.

This product is intended to prevent pregnancy. It does not protect against
HIV infection (AIDS) and other sexually transmitted diseases.

For Transdermal Use Only

Dosage: see Prescribing Information. Apply immediately upon removal
from pouch. Each transdermal system is intended to be worn 7 days as
prescribed.

Keep out of reach of children. Package not child-resistant.

Store in the pouch until ready for use. Store at 20°C to 25°C (68°F to
77°F); excursions permitted 15°C to 30°C (59°F to 86°F). [See USP
Controlled Room Temperature.] Do not store in the refrigerator or
freezer.

See Patient Information and Instructions for Use.

Note your Patch
Change Day here

Sunday

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

To discard: 1) fold the sticky sides together, 2) place in sturdy child-proof container,
and 3) place in the trash.

Distributed by:
Viatris Specialty LLC
Morgantown, WV 26505 U.S.A.

Gwyn Lo is a trademark of
Mylan Pharmaceuticals Inc., a Viatris Company.
© 2026 Viatris Inc.

VSL:627:222:3C:R1