NDC 0135-0195 Nicoderm CQ

Nicotine

NDC Product Code 0135-0195

NDC CODE: 0135-0195

Proprietary Name: Nicoderm CQ What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Nicotine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

NDC Code Structure

NDC 0135-0195-02

Package Description: 14 PATCH in 1 CARTON > 24 h in 1 PATCH

NDC 0135-0195-03

Package Description: 1 CARTON in 1 PACKAGE > 21 PATCH in 1 CARTON > 24 h in 1 PATCH

NDC 0135-0195-05

Package Description: 14 PATCH in 1 CARTON > 24 h in 1 PATCH (0135-0195-08)

NDC Product Information

Nicoderm CQ with NDC 0135-0195 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Nicoderm CQ is nicotine. The product's dosage form is patch, extended release and is administered via transdermal form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nicoderm CQ Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NICOTINE 14 mg/24h

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
FDA Application Number: NDA020165 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-12-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nicoderm CQ Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Patch)(Clear)

Nicotine, 21 mg delivered over 24 hours

Nicotine, 14 mg delivered over 24 hours

Nicotine, 7 mg delivered over 24 hours

Active Ingredient (In Each Patch)(Opaque)

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

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.

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

  • •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.

Directions (Clear)

  • •if you are under 18 years of age, ask a doctor before use •before using this product, read the enclosed User's 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 according to the following 10-week schedule:STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayWeeks 1-6Weeks 7-8Weeks 9-10 •if you smoke 10 or less cigarettes per day, do not use STEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks, then STEP 3 (7 mg) 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 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 User's 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 •it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Directions (Opaque)

  • •if you are under 18 years of age, ask a doctor before use •before using this product, read the enclosed User's 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 follow 10 week schedule:STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayWeeks 1-6Weeks 7-8Weeks 9-10 •if you smoke 10 or less cigarettes per day, do not use STEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks, then STEP 3 (7 mg) 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 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 User's 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 •to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures •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 •it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients (Clear)

Ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

Inactive Ingredients (Opaque)

Ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between pigmented and clear polyester backings

* Please review the disclaimer below.