AROAMAS COT NICOTINE TRANSDERMAL PATCHES KIT- nicotine transdermal patches patch 
PCHEERY LLC

----------

Initial Drug Listing - Aroamas Cot Patch Kit

Nicotine 21mg, 14mg, 7mg

menthol 0.3%

Stop smoking aid

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

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.

  • 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.

  • using a non-nicotine stop smoking drug
  • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

  • if you have vivid dreams or other sleep disturbances remove this patch at bedtime.

  • 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)

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.

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

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

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

PDP

AROAMAS COT NICOTINE TRANSDERMAL PATCHES KIT 
nicotine transdermal patches patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85831-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.3 g  in 100 
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE18 g  in 100 
Inactive Ingredients
Ingredient NameStrength
CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)  
CLOVE LEAF OIL (UNII: VCA5491KVF)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
CODONOPSIS PILOSULA ROOT (UNII: 02VJ3CEY9G)  
TOBACCO LEAF (UNII: 6YR2608RSU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:85831-032-0456 in 1 CARTON06/30/2025
11 in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/30/2025
Labeler - PCHEERY LLC (061286986)

Revised: 6/2025
Document Id: 38576022-9414-c9af-e063-6294a90afd46
Set id: 38576022-9413-c9af-e063-6294a90afd46
Version: 1
Effective Time: 20250624
 
PCHEERY LLC