Label: NICOTINE TRANSDERMAL PATCHES- aroamas nicotine transdermal patches - stop smoking aid patch
- NDC Code(s): 81799-002-01
- Packager: Ehy Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- 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.
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 - 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) - KEEP OUT OF REACH OF CHILDREN
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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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
NICOTINE TRANSDERMAL PATCHES
aroamas nicotine transdermal patches - stop smoking aid patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81799-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.3 mg in 100 mg NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 6 mg in 100 mg Inactive Ingredients Ingredient Name Strength CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L) CLOVE (UNII: K48IKT5321) CODONOPSIS PILOSULA WHOLE (UNII: 76AI4Q0335) TOBACCO LEAF (UNII: 6YR2608RSU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81799-002-01 21 in 1 BOX 03/30/2020 1 7 mg in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/30/2020 Labeler - Ehy Holdings LLC (117322715) Establishment Name Address ID/FEI Business Operations Ehy Holdings LLC 117322715 manufacture(81799-002)