Nicotine Patch
Nicotine Patch is an FDA drug label for the active ingredient NICOTINE manufactured by Guangzhou Yunzhen Trading Co., Ltd. administered by TRANSDERMAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260519.
- Generic name
- NICOTINE
- Manufacturer
- Guangzhou Yunzhen Trading Co., Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TRANSDERMAL
- Dosage form
- N/A
- NDC
- 87704-002
- Application
- 505G(a)(3)
- Label effective
- 20260519
About this product
Nicotine Patch is an FDA-registered drug product whose active ingredient is NICOTINE. It is labelled by Guangzhou Yunzhen Trading Co., Ltd. taken by transdermal and marketed as a human otc drug product. Identifiers on file: NDC 87704-002, application 505G(a)(3), label effective 20260519. It is one of 15 FDA drug label records sharing the active ingredient NICOTINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing NICOTINE are most often described in connection with: reduces withdrawal, symptoms including, nicotine craving, quitting smoking. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
Dosage & Administration
If you are under 18 years of age, ask a doctor beforeuse Before using this product, read the enclosed self-help guide for complete directions and other information· Begin using the patch on your quit day· If you smoke more than 10 cigarettes per day, use the following schedule below Weeks 1 thru 4 STEP 1:use one 21 mg patch/day Weeks 5 and 6 STEP 2:use one 14 mg patch/day Weeks 7 and 8 STEP 3:use one 7 mg patch/day · If you smoke <10 cigarettes/day: start with Step 2 for 6 weeks, then Step 3 for 2 weeks.· Under 18: ask a doctor before use.· Apply one new patch every 24 hours to dry, clean,hairless skin. Remove backing, press onto skin for 10 seconds. Wash hands after handling. Dispose of used patches by folding sticky ends together and placing in original pouch. Remove old patch and apply new one to a different skin site at the same time each day. If vivid dreams occur, remove patch at bedtime and apply new one in the morning Do not cut patch. Do not wear more than one patchat a time.· Do not leave on longer than 24 hours (may irritateskin and loses strength). Remove patch before MRI procedures to avoid burns.· Complete treatment. If you need to use longer to stay smoke-free, talk to your healthcare provider.
Warnings
If pregnant or breastfeeding, use only on advice of healthcare provider. Smoking seriously harms your child. Try to quit without nicotine replacement if possible. This medicine is believed safer than smoking, but risks to your child are not fully known.
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View labelHow products containing NICOTINE compare
FDA lists 15 drug label records with NICOTINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | H E B | 5 |
| — | — | Guangxi Keyun E-commerce Co., Ltd. | 3 |
| — | — | Costco Wholesale Company | 2 |
| — | — | A-S Medication Solutions | 1 |
| — | — | AmerisourceBergen Drug Corporation | 1 |
Frequently asked questions
What is Nicotine Patch used for?
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
Who makes Nicotine Patch?
Guangzhou Yunzhen Trading Co., Ltd. is the labeler of record for Nicotine Patch. 15 FDA label records share the active ingredient NICOTINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Nicotine Patch come in?
administered by transdermal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Nicotine Patch prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing NICOTINE?
Yes. 15 FDA drug label records list NICOTINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Nicotine Patch been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.