Nicotine Transdermal Patches

Manufacturer
Ehy Holdings LLC
Effective date
2023-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:05

Label at a glance#

ProductNicotine Transdermal Patches
Active ingredientMENTHOL, NICOTINE
Label structure12 sections

Dosage and administration

*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 1 STEP 2 STEP 3 Use one 21mg patch/day Use one 14mg patch/day Use one 7mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-10 *If you s...

Storage and handling

If you smoke more than 10 cigarettes per day, start with Step 1. lfyousmoke10or less cigarettes per day, Start with Step 2.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Nicotine 6%......Stop smoking aid
menthol 0.3%......Stop smoking aid

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare provider.Smoking can seriously harm your child.Try to stop smoking without using any nicotine replacement medicine.This medicine is believed to safer than smoking.However, the risks to your child from this medicine are not full known.

Ask a doctor before use if you have
*heart disease, recent heartattack, or irregular heartbeat.Nicotine can increase your heartrate.
*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 an on-nicotine stop smoking drug
*taking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted

Do not use

OTC - DO NOT USE SECTION

*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 if may irritate your skin and loses strength after 24 hours

OTC - WHEN USING SECTION

When using this product
*if you have vivid dreams or other sleep disturbances remove this patch at bedtime

OTC - STOP USE SECTION

Stop use and ask a doctor if
*skin redness caused by the patch does not go away after four days, or if your skins wells, or you get arash
*irregular heartbeat or palpitations occur
*you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat
*you have symptoms of an allergic reaction(such as difficulty breathing or rash)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 di posal.Dispose of the used patches by folding sticky ends together and putting in pouch.

Directions

DOSAGE & ADMINISTRATION SECTION

*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 3
Use one 21mg patch/dayUse one 14mg patch/dayUse one 7mg patch/day
Weeks 1-6Weeks 7-8Weeks 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.
*apply one new patch every 24 hours on skin that is dry, clean and hairless.
*remove backing from patch and immed ately press on to 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 sametime each day.
*if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning.
*you may wear the patch for 18 to 24 hours
*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 if may irritate your skin and loses strength after 24 hours
*to avoid possible burns, remove patch before undergoing and MR(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 healthcare provider.

Other information

STORAGE AND HANDLING SECTION

If you smoke more than 10 cigarettes per day, start with Step 1.
lfyousmoke10or less cigarettes per day, Start with Step 2.

Inactive ingredients

INACTIVE INGREDIENT SECTION

codonopsis pilosula, chrysanthemum, clove, natural tobacco

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

81799-002-01 7mg 1Patch 21PATCH 1BOX

81799-002-01 7mg 1Patch 21PATCH 1BOX81799-002-01 7mg 1Patch 21PATCH 1BOX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81799-002-012024-07-30C16284748780-11030e365-37a0-111a-e063-dadaa90a10e281799-002 Nicotine Transdermal Patches
81799-002-012024-01-30C16284748780-11030e365-37a0-111a-e063-dadaa90a10e281799-002 Nicotine Transdermal Patches

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81799-00281799-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f1e21df7-59d1-2245-e053-2995a90a82cfc2abe7b4-48a5-0555-e053-2995a90a390a2023-01-09WarningsExact identifier
spl id: f1e21df7-59d1-2245-e053-2995a90a82cf
spl set id: c2abe7b4-48a5-0555-e053-2995a90a390a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.