Initial Drug Listing - Aroamas Cot Patch Kit

Initial Drug Listing - Aroamas Cot Patch Kit
SPL v1
SPL
SPL Set ID 38576022-9413-c9af-e063-6294a90afd46
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.3 g) Nicotine (18 g)
Inactive Ingredients
Chrysanthemum Indicum Flower Clove Leaf Oil Camphor Oil Codonopsis Pilosula Root Tobacco Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

Nicotine 21mg, 14mg, 7mg menthol 0.3%


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

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 somke more than 10 cigarettes per day, use the following schedule below:

STEP 1

Use one 21 mg patch/day

Weeks 1-6



STEP 2

Use one 14 mg patch/day

Weeks 7-8



STEP 3

Use one 7 mg patch/day

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.
  • 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.
  • you may wear the patch for 18-24 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 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.
Description

Nicotine 21mg, 14mg, 7mg menthol 0.3%

Section 50565-1

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.

Section 50566-9
  • 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 difficulty breathing or rash)
Section 50567-7
  • if you have vivid dreams or other sleep disturbances remove this patch at bedtime.
Section 50568-5
  • using a non-nicotine stop smoking drug
  • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
Section 50569-3
  • 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.
Section 51727-6

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

Section 51945-4

Section 55105-1

Stop smoking aid

Section 55106-9

Nicotine 21mg, 14mg, 7mg

menthol 0.3%

Section 69762-3

Comments or Questions? Call toll-free: 833-276-2627 - Or visit us at aroamascot.com


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)
  • 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 somke more than 10 cigarettes per day, use the following schedule below:

STEP 1

Use one 21 mg patch/day

Weeks 1-6



STEP 2

Use one 14 mg patch/day

Weeks 7-8



STEP 3

Use one 7 mg patch/day

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.
  • 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.
  • you may wear the patch for 18-24 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 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.
Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)
  • 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 difficulty breathing or rash)
Section 50567-7 (50567-7)
  • if you have vivid dreams or other sleep disturbances remove this patch at bedtime.
Section 50568-5 (50568-5)
  • using a non-nicotine stop smoking drug
  • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
Section 50569-3 (50569-3)
  • 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.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Nicotine 21mg, 14mg, 7mg

menthol 0.3%

Section 69762-3 (69762-3)

Comments or Questions? Call toll-free: 833-276-2627 - Or visit us at aroamascot.com


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