Fixed-dose combination
Ethinyl estradiol and Norelgestromin is a fixed-dose combination of an estrogen and a progestin. It is available as transdermal patches. MedsAcross supplies Ethinyl estradiol and Norelgestromin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
GWYN LO is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. GWYN LO is a progestin/estrogen combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate.
Source: US FDA prescribing information
Combination hormonal contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation.
Source: US FDA prescribing information
• GWYN LO uses a 28-day (4-week) cycle. Apply a new TDS to the upper outer arm, abdomen, buttock or back each week for 3 weeks (21 total days). Week 4 is TDS-free. • Apply each new TDS on the same day of the week. Wear only one TDS at a time. • Do not cut or alter the TDS in any way.
Source: US FDA prescribing information
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 o Have deep vein thrombosis or pulmonary embolism, now or in the past o Have inherited or acquired hypercoagulopathies o Have cerebrovascular disease o Have coronary artery disease o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) o Have uncontrolled hypertension o Have diabetes mellitus with vascular disease o Have headaches with focal neurological symptoms or have…
Source: US FDA prescribing information
Boxed warning: Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including GWYN LO, are contraindicated in women who are over 35 years of age and smoke. • Vascular Risks: Stop GWYN LO if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all women, particularly those over 35 years. • Liver Disease: Discontinue GWYN LO if jaundice occurs. • Risk of Liver Enzyme Elevations with Concomitant Hepatitis C.
Source: US FDA prescribing information
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 • Liver Disease The most common adverse reactions (≥ 2%) in clinical trials for GWYN LO were application site irritation, application site erythema, application site pruritus, intercycle and heavy withdrawal bleeding, and nausea.
Source: US FDA prescribing information
Enzymes inducers (e.g., CYP3A4): May decrease the effectiveness of GWYN LO or increase breakthrough bleeding. Counsel women to use a back-up or alternative method of contraception when enzyme inducers are used with GWYN LO.
Source: US FDA prescribing information
Storage and Disposal Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). Do not store in the refrigerator or freezer. Store in original unopened pouch.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Ethinyl estradiol and Norelgestromin, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Zafemy 35 mcg/150 mcg per day transdermal patchTransdermal | Ethinyl estradiol and Norelgestromin | Amneal Pharmaceuticals | US FDA | Available on request |
| Xulane 35 mcg/150 mcg per day transdermal patchTransdermal | Ethinyl estradiol and Norelgestromin | Mylan Pharmaceuticals | US FDA | Available on request |
| Ethinyl estradiol and Norelgestromin 35 mcg/150 mcg per mg transdermal patchTransdermalGeneric name | Ethinyl estradiol and Norelgestromin | — | US FDA | Available on request |
| Ethinyl estradiol and Norelgestromin 35 mcg/150 mcg per day transdermal patchTransdermalGeneric name | Ethinyl estradiol and Norelgestromin | — | US FDA | Available on request |
| Gwyn Lo 20 mcg/220 mcg per day transdermal patchTransdermal | Ethinyl estradiol and Norelgestromin | Viatris Specialty | US FDA | Available on request |
3 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 5 presentations of Ethinyl estradiol and Norelgestromin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Ethinyl estradiol and Norelgestromin, including Gwyn Lo, Xulane, Zafemy.
Yes. The US FDA first approved Ethinyl estradiol and Norelgestromin on 20 November 2001, according to Drugs@FDA.
Yes. Ethinyl estradiol and Norelgestromin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Ethinyl estradiol and Norelgestromin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ethinyl estradiol and Norelgestromin is classified under ATC code G03AA13 (Ethinyl estradiol and Norelgestromin).
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