Initial Drug Listing - Aroamas Cot Patch Kit
- Manufacturer
- Haikou Pucao Trading Co.,Ltd
- Effective date
- 2025-02-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:40:58
Label at a glance#
ProductAroamas Cot Nicotine Transdermal Patches Kit
Active ingredientMENTHOL, NICOTINE
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Nicotine 21mg, 14mg, 7mg
menthol 0.3%
OTC - PURPOSE SECTION
Stop smoking aid
INDICATIONS & USAGE SECTION
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
WARNINGS SECTION
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.
OTC - ASK DOCTOR SECTION
- 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.
OTC - ASK DOCTOR/PHARMACIST SECTION
- 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 difficulty breathing or rash)
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
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 somke more than 10 cigarettes per day, use the following schedule below:
| STEP 1
Use one 21 mg patch/day | STEP 2
Use one 14 mg patch/day | STEP 3
Use one 7 mg patch/day |
| Weeks 1-6 | Weeks 7-8 | 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.
INACTIVE INGREDIENT SECTION
CODONOPSIS PILOSULA ROOT, CHRYSANTHEMUM INDICUM FLOWER, CLOVE LEAF OIL, TOBACCO LEAF, CAMPHOR OIL
TROUBLESHOOTING
Comments or Questions? Call toll-free: 833-276-2627 - Or visit us at aroamascot.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  stop-smoking.site/ | nicotine patches kit PDP.jpg |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Aroamas Cot Nicotine Transdermal Patches Kit
- Nicotine Transdermal Patches
- CODONOPSIS PILOSULA ROOT
- CHRYSANTHEMUM INDICUM FLOWER
- TOBACCO LEAF
- CLOVE LEAF OIL
- CAMPHOR OIL
- MENTHOL
- NICOTINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85261-501 | 85261-501-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CODONOPSIS PILOSULA ROOT | 02VJ3CEY9G | IACT |
| CHRYSANTHEMUM INDICUM FLOWER | I6OER6U04L | IACT |
| TOBACCO LEAF | 6YR2608RSU | IACT |
| CLOVE LEAF OIL | VCA5491KVF | IACT |
| CAMPHOR OIL | 75IZZ8Y727 | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| NICOTINE | 6M3C89ZY6R | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 450f3b5c-36e4-a4cf-e063-6294a90a0e65 | 2e08f148-84e1-82d5-e063-6394a90ae286 | 2025-12-03 | Warnings | 2e08f148-84e1-82d5-e063-6394a90ae286 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.