AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3

Manufacturer
PCHEERY LLC
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:29:09

Label at a glance#

ProductAROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3
Active ingredientMENTHOL, NICOTINE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Nicotine 6%

Menthol 0.3%

OTC - PURPOSE SECTION

Stop smoking aid

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

lf you are pregnant or breast-feeding, only use this medicine on the advice ofyour health care 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 fully known.

OTC - ASK DOCTOR SECTION

If you have

  • Heart disease, recent heart attack, or ireqular heartbeat, Nicotine can increase your heart rate.
  • High blood pressurenot controlled with medication. Nicotine can increase your blood pressure.
  • An allergy to adhesive tape or have skinproblems, because you are more likely to get rashes.
  • Stomach ulcer or diabetes.
  • History of seizures.

OTC - ASK DOCTOR/PHARMACIST SECTION

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.

OTC - WHEN USING SECTION

If you have vivid dreams or other sleep disturbances, remove this patch at bedtime.

OTC - STOP USE SECTION

  • 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.
  • You have symptoms of an allergic reaction (such as diffculty breathing or rash)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Used patches have enough nicotine to poison children and pets. lf swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the usedpatches by folding sticky ends together and putting in pouch.

INDICATIONS & USAGE SECTION

  • if you are under 18 years of age, ask a doctor before use.
  • before using this product, read the enclosed self help guidefor complete directions and other information
  • begin using the patch on your quit day
  • if you smoke more than 10cigarettes per day,
  • use the following schedule below:

stepstep

  • lf 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 Step3(7 mg) for 2 weeks and then stop.
  • apply one new patch every 24 hours on skin that is dry, clean and hairless.
  • removebacking from patch and immediately press onto skin. Hold for 10 seconds.
  • wash hands after applying or removing patchSave 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 havevivid dreams, you may remove the patch at bedtime and apply a new one in the morning.
  • you may wear the patch for 18to 24 hours
  • do not wear more than one patch at a time
  • do not cut patch in half or into smaller pieces
  • do not leavepatch on for more than 24 hours because if may irritate your skin and loses strength after 24 hours
  • to avoid possibleburns, remove patch before underaoing and MRllmaanetic resonance imaging) procedures
  • it is important to complete treatment. lf you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

INACTIVE INGREDIENT SECTION

CODONOPSIS PILOSULA ROOT, CHRYSANTHEMUM INDICUM FLOWER,CLOVE LEAF OIL,TOBACCO LEAF, CAMPHOR OIL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codestop-smoking.site/package.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85831-035-01AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 31 in 1 PATCHPATCH11
85831-035-01AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 321 in 1 CARTONPATCH211

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85831-03585831-035-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
ndc (package): 85831-035-01
ndc (product): 85831-035
ndc11 (package): 85831003501
spl id: 45811e83-8d0c-bc2a-e063-6294a90adf50
spl set id: 45811e83-8d0b-bc2a-e063-6294a90adf50

Reported adverse events (FAERS/openFDA)#

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