Active Ingredient
Nicotine 21mg
Nicotine Patches Patch
FDA Label NDC 85795-002
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 Telafaerjialuo Technology Co., Ltd. for the product Nicotine Patches (NDC 85795-002). 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
reduces withdrawal symptoms, including nicotine cravings associated with quitting smoking.
Warnings
For external use only
Do Not Use
heart disease , high blood pressure , skin sensitivity or rash , diabetes , history of seizures
When Using
if you have vivid dreams or other sleep disturbances remove this patch at bedtime
Stop Use
if irritation or allergic reactions occur
Ask Doctor
using a non-nicotine stop smoking drug , pregnant or breast-feeding
Keep Out Of Reach Of Children
In case of accidental ingestion,seek medical advice immediatelyor contact aPoison Control Center(1-800-222-1222)
Directions
if you are under 18 years of age,ask a doctor before use.
Before use,carefully read the insert for complete instructions.
Ifyou smoke more than 10 cigarettes per day,follow this 10-week schedule:
lf you smoke 10 or fewer cigarettes per day,skip STEP1(21 mg).Start with STEP 2(14 mg)for 6
weeks-using two 14 mg patches per day for the first week,then one 14 mg patch per day for weeks 2 to 6.Then move to STEP3(7mg)for 2 weeks,and stop.
Other Information
Store at 20-25°℃(68-77°F)
Inactive Ingredients
camphor , ethanol , acrylate adhesive , aluminized polyester , cellulose paper , methacryic acid copolymer
Questions
Contactus at:[email protected]
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