Label: NICOTINE PATCHES tablet

  • NDC Code(s): 84335-123-01, 84335-123-02
  • Packager: Adam E-commerce (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 17, 2024

If you are a consumer or patient please visit this version.

  • WARNINGS

    Warnings
    It you are pregnant or breast-feeding,only use this medicine on the advice of yourhealth care provider.
    Smoking can seriously harm your child.Try to stop smoking
    withou using any nicotine repiacement medicie.This medicineisbelieve(to be safer than smoking.However therisksto your childfrom this medicine are not fuly known

  • INACTIVE INGREDIENT

    Medium-chain Triglycerides, Basic Butylated MethacrylateCopolymer, Polyethylenterephthalate Film (Pet),

    AcrylicAdhesive solution, Potassium Hydroxide, CroscarmelloseSodium,Aluminium Acetylacetonate, Siliconised Pet ReleaseLiner With Aluminised Single Side, Printing Inks

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and petsUsed patches have enough nicotine to poison children andpets.lf swallowed , get medical help or contact a poisoncontrol center right away . Save pouch to use for patchdisposal.Dispose of the used patches by folding sticky endstogether and putting in pouch

  • PURPOSE

    1 Helps You Quit Smoking.2 Controls Nicotine Cravings,3 Fights Withdrawal Symptoms.4 100% Natural Plant Based.

  • INDICATIONS & USAGE


    Helps You Quit Smoking. Controls Nicotine Cravings. Fights Withdrawal Symptoms. 100% Natural Plant Based.

  • DOSAGE & ADMINISTRATION

    lf you smoke 10 or less cigarettes per day, start with Step2 for 6 weeks, then step 3 for 2 weeks.Apply one new patch every 24 hours on skin that is dry,clean and hairless.
    Remove backing from patch and immediatety press ontoskin.Hold for 10 seconds.
    Wash hands after applying or removing patch。 Save pouchto use for patch disposal. Dispose of the used patches byfolding sticky ends together and putting in pouch.The used patch should be removed and a new oneapplied to a different skin site at the same time each daylf you have vivid dreams,you may remove the patch atbedtime and apply a new one in the morning.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 itmay irritate your skin and loses strength after 24 hours。

    To avoid possible burns, remove patch before undergoingany MRl (magnetic resonance imaging) procedures.lt is important to complete treatment. lf you feel you needto use the patch for a longer period to keep from smokingtalk to you health care provider.

  • ACTIVE INGREDIENT

    Nicotine, PsA, camphor

  • PRINCIPAL DISPLAY PANEL

    11

  • INGREDIENTS AND APPEARANCE
    NICOTINE PATCHES 
    nicotine patches tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84335-123
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSATHYROTES RAMOSISSIMA WHOLE (UNII: 99923O3L19) (PSATHYROTES RAMOSISSIMA WHOLE - UNII:99923O3L19) PSATHYROTES RAMOSISSIMA WHOLE36 g  in 100 g
    N-(HYDROXYMETHYL)NICOTINAMIDE (UNII: 1N1YGM997E) (N-(HYDROXYMETHYL)NICOTINAMIDE - UNII:1N1YGM997E) N-(HYDROXYMETHYL)NICOTINAMIDE36 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ALUMINUM ACETYLACETONATE (UNII: 77S22ZW4U3)  
    CAMPHORIC ACID, (+)- (UNII: W77RM1CSD5)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeFREEFORMSize22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84335-123-0230 in 1 BOX05/17/2024
    1NDC:84335-123-0121 g in 1 PATCH; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/17/2024
    Labeler - Adam E-commerce (Xiamen) Co., Ltd. (416792461)