Nicotine Transdermal System
Nicotine
Sam's West Inc
Human Otc Drug
NDC 68196-194Nicotine Transdermal System also known as Nicotine is a human otc drug labeled by 'Sam's West Inc'. National Drug Code (NDC) number for Nicotine Transdermal System is 68196-194. This drug is available in dosage form of Patch, Extended Release. The names of the active, medicinal ingredients in Nicotine Transdermal System drug includes Nicotine - 21 mg/24h . The currest status of Nicotine Transdermal System drug is Active.
Drug Information:
| Drug NDC: | 68196-194 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Nicotine Transdermal System |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Nicotine |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | transdermal system |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Nicotine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sam's West Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch, Extended Release |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | NICOTINE - 21 mg/24h
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TRANSDERMAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 02 Mar, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA020165 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sam's West Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198030
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175706
M0014836
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 6M3C89ZY6R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Cholinergic Nicotinic Agonist [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Nicotine [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Cholinergic Nicotinic Agonist [EPC]
Nicotine [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68196-194-03 | 21 PATCH in 1 CARTON (68196-194-03) / 24 h in 1 PATCH | 02 Mar, 2012 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose stop smoking aid
Product Elements:
Nicotine transdermal system nicotine nicotine nicotine ethylene-vinyl acetate copolymer (40% vinyl acetate) high density polyethylene
Indications and Usage:
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Warnings:
Warnings 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. do not use ⢠if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products ask a doctor before use if you have ⢠heart disease, recent heart attack, or irregular heartbeat. nicotine can increase your heart rate. ⢠high blood pressure not controlled with medication. nicotine can increase your blood pressure. ⢠an allergy to adhesive tape or have skin problems because you are more likely to get rashes. ask a doctor or pharmacist before use if you are ⢠using a non-nicotine stop smoking drug ⢠taking a prescription medicine for depression or asthma. your prescription do
Read more...se may need to be adjusted. when using this product ⢠do not smoke even when not wearing the patch. the nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. ⢠if you have vivid dreams or other sleep disturbances remove this patch at bedtime stop use and ask a doctor if ⢠skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash ⢠irregular heartbeat or palpitations occur ⢠you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat keep out of reach of children and pets. used patches have enough nicotine to poison children and pets. if swallowed, get medical help or contact a poison control center right away. dispose of the used patches by folding sticky ends together. replace in pouch and discard.
Do Not Use:
Warnings 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. do not use ⢠if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products ask a doctor before use if you have ⢠heart disease, recent heart attack, or irregular heartbeat. nicotine can increase your heart rate. ⢠high blood pressure not controlled with medication. nicotine can increase your blood pressure. ⢠an allergy to adhesive tape or have skin problems because you are more likely to get rashes. ask a doctor or pharmacist before use if you are ⢠using a non-nicotine stop smoking drug ⢠taking a prescription medicine for depression or asthma. your prescription dose may need to be adjusted. when using this product ⢠do not smoke even when not wearing the patch. the nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. ⢠if you have vivid dreams or other sleep disturbances remove this patch at bedtime stop use and ask a doctor if ⢠skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash ⢠irregular heartbeat or palpitations occur ⢠you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat keep out of reach of children and pets. used patches have enough nicotine to poison children and pets. if swallowed, get medical help or contact a poison control center right away. dispose of the used patches by folding sticky ends together. replace in pouch and discard.
When Using:
When using this product ⢠do not smoke even when not wearing the patch. the nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. ⢠if you have vivid dreams or other sleep disturbances remove this patch at bedtime
Dosage and Administration:
Directions ⢠if you are under 18 years of age, ask a doctor before use ⢠before using this product, read the enclosed userâs guide for complete directions and other information ⢠stop smoking completely when you begin using the patch ⢠if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule: step 1 step 2 step 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day weeks 1-6 weeks 7-8 weeks 9-10 ⢠if you smoke 10 or less cigarettes per day, do not use step 1 (21mg). start with step 2 (14mg) , for 6 weeks, then step 3 (7mg) for 2 weeks and then stop. ⢠steps 2 and 3 allow you to gradually reduce your level of nicotine. completing the full program will increase your chances of quitting successfully. ⢠apply one new patch every 24 hours on skin that is dry, clean and hairless. save pouch for disposing of the patch after use. ⢠remove backing from patch and immediately press onto skin. hold
Read more...for 10 seconds. ⢠wash hands after applying or removing patch. throw away the patch by folding sticky ends together. replace in its pouch and discard. see enclosed userâs guide for safety and handling. ⢠you may wear the patch for 16 or 24 hours ⢠if you crave cigarettes when you wake up, wear the patch for 24 hours ⢠if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning ⢠the used patch should be removed and a new one applied to a different skin site at the same time each day ⢠do not wear more than one patch at a time ⢠do not cut patch in half or into smaller pieces ⢠do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours ⢠stop using the patch at the end of 10 weeks. if you started with step 2 , stop using the patch at the end of 8 weeks. if you still feel the need to use the patch, talk to your doctor.
Stop Use:
Stop use and ask a doctor if ⢠skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash ⢠irregular heartbeat or palpitations occur ⢠you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat
Package Label Principal Display Panel:
Principal display panel ndc 68196-194-03 nicotine patch nicotine transdermal system 21mg delivered over 24 hours stop smoking aid 21 mg simply right ⢠health care compare to nicoderm ® cq ® * includes behavior support program enrollment form & userâs guide if you smoke more than 10 cigarettes per day: start with step 1 if you smoke 10 or less cigarettes per day: start with step 2 step 1 21 clear patches ©2011 101775xa 101775xa nicotine patch sams 21 mg 21 ct carton
Further Questions:
Questions or comments? call toll-free 1-866-255-5205 (english/spanish) weekdays to increase your success in quitting: ⢠you must be motivated to quit. ⢠complete the full treatment program, applying a new patch every day. ⢠use with a support program as described in the enclosed userâs guide. for your familyâs protection, nicotine patches are supplied in child-resistant pouches. do not use if individual pouch/packet is damaged or open. nicotine transdermal system 21 mg delivered over 24 hours stop smoking aid ⢠not for sale to those under 18 years of age. ⢠prrof of age required. ⢠not for sale in vending machines or from any source where proof of age cannot be verified. free audio cd upon request. see inside. what is the nicotine patch and how is it used? nicotine patch is a small, nicotine-containing patch. when you put on a nicotine patch, nicotine passes through the skin and into your body. nicotine patch is very thin and uses special material to control how fast nicotine passes through the skin. unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16-hour period you wear the nicotine patch. this helps to reduce cravings you may have for nicotine. read carton and enclosed userâs guide before using this product. keep the carton and userâs guide. they contain important information. the simply right⢠promise simply right is dedicated to providing healthful, gentle, and safe personal care products for the entire family. we continuously strive to be your trusted partner in wellness and exceed your expectations. we would like to hear from you with any comments or suggestions. in the continental us or canada, you can call us toll-free at 1-800-255-5205, monday through friday, from 8 am to 5 pm cst. or you can send us an email at samsclub.com. distributed by: samâs west, inc. bentonville, ar 72716 *nicoderm is a licensed trademark of the glaxosmithkline group of companies. satisfaction guaranteed by refund or exchange made in switzerland send comments/questions to: gcsp 5.4376.4c consumer relations p.o. box 13398 research triangle park, nc 27709-9627