AROAMAS COT NICOTINE TRANSDERMAL PATCHES KIT- nicotine transdermal patches patch

Aroamas Cot Nicotine Transdermal Patches Kit by

Drug Labeling and Warnings

Aroamas Cot Nicotine Transdermal Patches Kit by is a Otc medication manufactured, distributed, or labeled by Haikou Pucao Trading Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Nicotine 21mg, 14mg, 7mg

menthol 0.3%

PURPOSE

Stop smoking aid

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & 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	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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AROAMAS COT NICOTINE TRANSDERMAL PATCHES KIT 
nicotine transdermal patches patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85261-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.3 g  in 100
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	18 g  in 100

Inactive Ingredients
Ingredient Name	Strength
CODONOPSIS PILOSULA ROOT (UNII: 02VJ3CEY9G)
CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
TOBACCO LEAF (UNII: 6YR2608RSU)
CLOVE LEAF OIL (UNII: VCA5491KVF)
CAMPHOR OIL (UNII: 75IZZ8Y727)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85261-501-04	56 in 1 CARTON	02/28/2025
1		1 in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/28/2025

Labeler - Haikou Pucao Trading Co.,Ltd (621948245)