SPL v1
SPL
SPL Set ID 19336340-ad3d-62b7-e063-6294a90affed
Route
PERCUTANEOUS
Published
Effective Date 2024-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psathyrotes Ramosissima Whole (36 g) N-(hydroxymethyl)nicotinamide
Inactive Ingredients
Croscarmellose Sodium Potassium Hydroxide Aluminum Acetylacetonate Camphoric Acid, (+)- Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Shape: freeform Color: yellow Size: 22 mm Score: 2
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-05-17

Description

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


Medication Information

Warnings and Precautions

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

Indications and Usage



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

Dosage and 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.

Description

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

Section 50565-1

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

Section 51727-6

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

Section 51945-4

1

Section 55105-1

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

Section 55106-9

Nicotine, PsA, camphor


Structured Label Content

Indications and Usage (34067-9)



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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

1

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Nicotine, PsA, camphor


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)