Package Label.Principal Display Panel
Drug Facts
Sielkin Quit Smoking Nicotine Patches Patch
FDA Label NDC 83364-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yitongbada (shenzhen) International Trade Co., Ltd for the product Sielkin Quit Smoking Nicotine Patches (NDC 83364-015). 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 package label.principal display panel, otc - active ingredient, otc - purpose, indications & usage, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, 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 - Active Ingredient
Active ingredients (in each patch)
Nicotine 7mg delivered over 24 hours
Otc - Purpose
Stop smoking aid
Indications & Usage
reduces withdrawal symptoms, including nicotine cravings associated with quitting smoking.
Otc - Ask Doctor
Ask a doctor before use if you have
■heart disease ■high blood pressure ■skin allergies ■diabetes ■history of seizures
Stop use and ask a doctor if irritation or allergic reactions occur
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are■using a non-nicotine stop smoking drug■pregnant or breast-feeding
Otc - When Using
When using this product
if you have vivid dreams or other sleep disturbances remove this patch at bedtime.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center(1-800-222-1222)
Warnings
Warnings
For external use only
Dosage & Administration
Directions
■
if you are under 18 years of age, ask a doctor before use.
■Before use, carefuly read the insert for complete instructions.
■lf you smoke more than 10 cigarettes per day, follow this 10-week schedule:
| Step 1 | Step 2 | Step 3 | ||
Cigarettes per Day | Week 1(Key Adjustment Phase) | Weeks 2-6 | Weeks 7-8 | Weeks 9-10 |
| 10-20 cigarettes | two 21mg patch/day | one 21mg patch/day | one 14mg patch/day | one 7 mg patch/day |
| 20+ cigarettes | three 21mg patch/day | two 21mg patch/day | one 14mg patch/day | one 7 mg patch/day |
■lf you smoke 10 or fewer cigarettes per day, skip STEP 1(21mg). Start with STEP 2(14mg) for 6 weeks-using two14mg patches per day for the first week, then one 14mg patch per day for weeks 2 to 6. Then move to STEP 3(7mg) for 2weeks, and stop.
Other Safety Information
Other information Store at 20-25℃ (68-77°F)
Inactive Ingredient
Inactive ingredients camphor, ethanol, acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer
* Please review the disclaimer below.
