Active Ingredient
Nicotine: 28 mg
Elsophie Nicotine Patches Quit Patch
FDA Label NDC 83818-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Elsophie Nicotine Patches Quit (NDC 83818-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
stop smoking aid
Use
Helps reduce withdrawal symptoms, such as nicotine cravings, during smoking cessation
Warnings
Keep away from children/pets
Do Not Use
If you are allergic to nicotine or any adhesive patches.
If you are pregnant or breastfeeding, unless directed by a doctor.
When Using
Avoid smoking or using other nicotine-containing products to prevent nicotine overdose.
Stop Use
If you experience severe skin irritation, irregular heartbeat, or symptoms of nicotine overdose (e.g., dizziness, nausea, vomiting).
Ask Doctor
Before use if you have heart disease, high blood pressure, or are taking prescription medication.
Keep Out Of Reach Of Children
Accidental ingestion or application may cause serious harm or death.
Directions
Apply one patch to a clean, dry, and hairless area of skin (e.g., upper arm or torso).
Replace the patch every 24 hours with a new one.
Rotate application sites to avoid skin irritation.
Other Information
Store at room temperature (15–30°C/59–86°F).
Avoid exposure to direct sunlight or excessive heat.
Inactive Ingredients
Acrylate adhesive, polyethylene film, silicone release liner.
Questions
For more information, contact VINER INC. at:
Address: 742 South Meadow St, Suite 200, Ithaca, NY 14850, USA.
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