Otc - Active Ingredient
menthol
The following Structured Product Label (SPL) was submitted to the FDA by Jiashen International Trade Limited for the product Bulpol Smoking Patches (NDC 84867-017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, otc - ask doctor, otc - keep out of reach of children, indications & usage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
menthol
Stop smoking aid
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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 or pharmacist before use ifyou are"usinga non-nicotine stop smoking drugtaking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted.
Keep out of reach of children and pets.
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 di posal.Dispose of the used patches by folding sticky ends together and putting in pouch.
ifyou smoke 10 orless cigarettes per day, do not useSTEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks,then STEP 3 (7 mg) for 2 weeks and then stop.steps 2 and 3 allow you to gradually reduce yourlevel ofnicotine.Completingthe full program willincrease yourchances ofquittingsuccessfully.apply one new patch every 24 hours on skin that is dry, cleanand hairless. Save pouch for disposingofthe patch after use.remove backingfrom patch andimmediately press onto skin.Hold for 10 seconds.
STEP1
Use one 21 mgpatch/day
Weeks 1-6
STEP 2
Use one 14 mg
patch/day
Weeks 7-8
STEP 3
Use one7mg
patch/day
Weeks9-10
nactive ingredientsethylene vinylacetate-copolymer, polyisobutylene and high densitypolyethylene between clearpolyester backings
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