Label: AROAMAS COT NICOTINE TRANSDERMAL PATCHES KIT- nicotine transdermal patches patch
- NDC Code(s): 85831-032-04
- Packager: PCHEERY LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 24, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
- 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)
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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
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.
- INACTIVE INGREDIENT
- TROUBLESHOOTING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AROAMAS COT NICOTINE TRANSDERMAL PATCHES KIT
nicotine transdermal patches patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:85831-032 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:85831-032-04 56 in 1 CARTON 06/30/2025 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 06/30/2025 Labeler - PCHEERY LLC (061286986)
