AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3- nicotine transdermal patches patch

AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3 by

Drug Labeling and Warnings

AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3 by is a Otc medication manufactured, distributed, or labeled by PCHEERY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Nicotine 6%

Menthol 0.3%

PURPOSE

Stop smoking aid

DOSAGE & ADMINISTRATION

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

WARNINGS

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.

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.

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.

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 diffculty breathing or rash)

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

• 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:

• 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3 
nicotine transdermal patches patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85831-035
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	6 g  in 100

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85831-035-01	21 in 1 CARTON	12/30/2025
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	12/30/2025

Labeler - PCHEERY LLC (061286986)