Label: AROAMAS COT NICOTINE TRANSDERMAL PATCHES- nicotine transdermal patches patch
- NDC Code(s): 82739-026-01
- Packager: Shenzhen Situya Trading Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare 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 full known.
- Do not use
- When Using
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Stop Use
Stop use and ask a doctor if
*skin redness caused by the patch does not go away after four days, or if your skins wells, or you get arash
*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) -
Ask Doctor
Ask a doctor before use if you have
*heart disease, recent heartattack, or irregular heartbeat.Nicotine can increase your heartrate.
*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.Ask a doctor or pharmacist before use if you are
*using an on-nicotine stop smoking drug
*taking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted - Keep Oot Of Reach Of Children
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Directions
Directions
*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 smoke more than 10 cigarettes per day, use the following schedule below:STEP 1 STEP 2 STEP 3
Use one 21mg patch/day Use one 14mg patch/day Use one 7mg 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 immed ately press on to 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 sametime 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 to 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 if may irritate your skin and loses strength after 24 hours
*to avoid possible burns, remove patch before undergoing and MR(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 healthcare provider. - Other information
- Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AROAMAS COT NICOTINE TRANSDERMAL PATCHES
nicotine transdermal patches patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82739-026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 6 g in 100 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.3 g in 100 Inactive Ingredients Ingredient Name Strength TOBACCO LEAF (UNII: 6YR2608RSU) CODONOPSIS PILOSULA ROOT (UNII: 02VJ3CEY9G) CAMPHOR OIL (UNII: 75IZZ8Y727) CLOVE LEAF OIL (UNII: VCA5491KVF) CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82739-026-01 21 in 1 BOX; Type 0: Not a Combination Product 09/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 09/02/2024 Labeler - Shenzhen Situya Trading Co., Ltd. (706154255) Establishment Name Address ID/FEI Business Operations Shenzhen Situya Trading Co., Ltd. 706154255 manufacture(82739-026) , label(82739-026)