Otc - Active Ingredient
NICOTINE(21mg)
Nicotine Stop Smoking Aid Patch
FDA Label NDC 87278-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Nicotine Stop Smoking Aid (NDC 87278-009). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Stop Smoking Aid
Indications & Usage
Helps reducewithdrawal symptoms,such as nicotine cravings,duringsmokingcessation.
Warnings
For external use only,flammable,keep awayfromheat or flame
Otc - Do Not Use
Not for non-smokers.
Keep away from children/pets.·Consult doctor if pregnant/nursing.
Otc - When Using
When using section. Avoid smoking or using other nicotine-containing products to prevent nicotine overdose
Otc - Stop Use
OTC- Stop Use Section.lf you experience severe skin irritation, rregular heartbeat, or: symptoms of nicotine overdose(e.g.,dizziness, nausea, vomiting)
Otc - Keep Out Of Reach Of Children
Keep away from children/pets..Consult doctor if pregnant/nursing
Dosage & Administration
Apply one patch to a clean,dry,and hairless area of skin (e.g.,upper arm or torso)
Replace thepatchevery24hourswithanewone.
Rotate application sites to avoid skin irritation.
Step1+(28mg)-For smokers of 10+ cigarettes/day.
Applyonupperarm/hip;avoidbrokenskin.
Replaceafter24hours.
Inactive Ingredient
2-Hydroxyethyl Acrylate
Powdered Cellulose
Methacrylic Acid
Package Label.Principal Display Panel
Label5 (Label5)
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