FDA Label for Norelgestromin And Ethinyl Estradiol
View Indications, Usage & Precautions
Norelgestromin And Ethinyl Estradiol Product Label
The following document was submitted to the FDA by the labeler of this product Zydus Lifesciences Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.Principal Display Panel
NDC 70771-1777-3
Norelgestromin and Ethinyl Estradiol Transdermal System 150/35 mcg per day
This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
For Transdermal Use Only
Contents: 3 Transdermal Systems
Rx only
Each 15.75 cm2 system contains 4.678 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP. The inactive components are polyisobutylene/polybutene adhesive, crospovidone, lauryl lactate, non-woven polyester fabric, polyester backing film laminate and polyester release liner.
See patient instructions. Apply immediately upon removal from pouch. Each transdermal system is intended to be worn 7 days as prescribed.
Package not child-resistant. Keep out of reach of children.
Do not store unpouched. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Manufactured by:
Zydus Lifesciences Ltd.
Ahmedabad, India
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
Rev.: 10/22
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