NDC 55910-313 Nicotine Transdermal System Step 1

Nicotine

NDC Product Code 55910-313

NDC 55910-313-02

Package Description: 2 PATCH in 1 CARTON > 24 h in 1 PATCH

NDC Product Information

Nicotine Transdermal System Step 1 with NDC 55910-313 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Nicotine Transdermal System Step 1 is nicotine. The product's dosage form is patch, extended release and is administered via transdermal form.

Labeler Name: Dolgencorp, 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.

Nicotine Transdermal System Step 1 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 21 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.

  • METHACRYLIC ACID (UNII: 1CS02G8656)

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.

Product Labeler Information

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

Labeler Name: Dolgencorp, Llc
Labeler Code: 55910
FDA Application Number: NDA020076 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: 06-15-2019 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.

Nicotine Transdermal System Step 1 Product Label Images

Nicotine Transdermal System Step 1 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 Step 1 (In Each Patch)

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid

Use

Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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.

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.stomach ulcer or diabetes.history of seizures.

Ask A Doctor Or Pharmacist Before Use If You Are

  • Using a non-nicotine stop smoking drugtaking 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 rashirregular heartbeat or palpitations occuryou get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeatyou have symptoms of an allergic reaction (such as difficulty breathing or rash)

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. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Directions

  • •if you are under 18 years of age, ask a doctor before use •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: STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayWeeks 1-4Weeks 5-6Weeks 7-8 •if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks •apply one new patch every 24 hours on skin that is dry, clean and hairless •remove backing from patch and immediately press onto skin. Hold for 10 seconds. •wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. •the used patch should be removed and a new one applied to a different skin site at the same time each day •if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning •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 •to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures •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

Acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

* Please review the disclaimer below.