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
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 healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NICOTINE PATCHES
nicotine patches tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84335-123 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSATHYROTES RAMOSISSIMA WHOLE (UNII: 99923O3L19) (PSATHYROTES RAMOSISSIMA WHOLE - UNII:99923O3L19) PSATHYROTES RAMOSISSIMA WHOLE 36 g in 100 g N-(HYDROXYMETHYL)NICOTINAMIDE (UNII: 1N1YGM997E) (N-(HYDROXYMETHYL)NICOTINAMIDE - UNII:1N1YGM997E) N-(HYDROXYMETHYL)NICOTINAMIDE 36 g in 100 g Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) ALUMINUM ACETYLACETONATE (UNII: 77S22ZW4U3) CAMPHORIC ACID, (+)- (UNII: W77RM1CSD5) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color yellow Score 2 pieces Shape FREEFORM Size 22mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84335-123-02 30 in 1 BOX 05/17/2024 1 NDC:84335-123-01 21 g in 1 PATCH; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/17/2024 Labeler - Adam E-commerce (Xiamen) Co., Ltd. (416792461)
1