Otc - Active Ingredient
nicotine
Sefudun Quit Smoking Nicotine Patches Patch
FDA Label NDC 83804-001
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 Shandian Jingling Technology Co., Ltd. for the product Sefudun Quit Smoking Nicotine Patches (NDC 83804-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
nicotine patch
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN SECTION
Warnings
For external use only
Dosage & Administration
1. Clean your arms thoroughly
2. Take out the patch and stick it on your arm
3. Valid for up to 24 hours
Inactive Ingredient
methacrylic acid copolymer
POLYESTER-5 (TG-38)
ACRYLIC ACID
Indications & Usage
Use reduces withdrawal symptoms, ineluding nicotine cravingassocated with qultting sroking
Package Label.Principal Display Panel
Label2 (Label2)
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