Active Ingredient (In Each Patch)
Step 1 - Nicotine, 21 mg delivered over 24 hours
Step 2 - Nicotine, 14 mg delivered over 24 hours
Step 3 - Nicotine, 7 mg delivered over 24 hours
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Nicotine Transdermal System (NDC 36800-034). 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 (in each patch), purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Step 1 - Nicotine, 21 mg delivered over 24 hours
Step 2 - Nicotine, 14 mg delivered over 24 hours
Step 3 - Nicotine, 7 mg delivered over 24 hours
Stop smoking aid
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.
Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
| Weeks 1 thru 2 | Weeks 5 and 6 | Weeks 7 and 8 |
| Step 1 | Step 2 | Step 3 |
| Use one 21 mg patch/day | Use one 14 mg patch/day | Use one 7 mg patch/day |
store at 20° C – 25° C (68° F – 77° F)
acrylate adhesive, polyester, silicone adhesive
1-844-562-7963
1. You must be motivated to quit.
2. Use one patch daily according to directions.
3. It is important to complete treatment.
4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
5. Use patch with a behavioral support program such as the one described in the enclosed booklet.
* Please review the disclaimer below.