Nicotine Patches

Manufacturer
Shenzhen TeLaFaErJiaLuo Technology Co., Ltd.
Effective date
2025-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:07:33

Label at a glance#

ProductNicotine Patches
Active ingredientNICOTINE
Label structure14 sections

Dosage and administration

if you are under 18 years of age,ask a doctor before use. Before use,carefully read the insert for complete instructions. Ifyou smoke more than 10 cigarettes per day,follow this 10-week schedule: lf you smoke 10 or fewer cigarettes per day,skip STEP1(21 mg).Start with STEP 2(14 mg)for 6 weeks-using two 14 mg patches per day for the first week,then one 14 mg patch per day for weeks 2 to 6.Then move to STEP3(7mg)for...

Storage and handling

Store at 20-25°℃(68-77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Nicotine 21mg

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

reduces withdrawal symptoms, including nicotine cravings associated with quitting smoking.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

heart disease , high blood pressure , skin sensitivity or rash , diabetes , history of seizures

When Using

OTC - WHEN USING SECTION

if you have vivid dreams or other sleep disturbances remove this patch at bedtime

Stop Use

OTC - STOP USE SECTION

if irritation or allergic reactions occur

Ask Doctor

OTC - ASK DOCTOR SECTION

using a non-nicotine stop smoking drug , pregnant or breast-feeding

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion,seek medical advice immediatelyor contact aPoison Control Center(1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

if you are under 18 years of age,ask a doctor before use.
Before use,carefully read the insert for complete instructions.
Ifyou smoke more than 10 cigarettes per day,follow this 10-week schedule:
lf you smoke 10 or fewer cigarettes per day,skip STEP1(21 mg).Start with STEP 2(14 mg)for 6
weeks-using two 14 mg patches per day for the first week,then one 14 mg patch per day for weeks 2 to 6.Then move to STEP3(7mg)for 2 weeks,and stop.

Other information

STORAGE AND HANDLING SECTION

Store at 20-25°℃(68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor , ethanol , acrylate adhesive , aluminized polyester , cellulose paper , methacryic acid copolymer

Questions

OTC - QUESTIONS SECTION

Contactus at:BURRRER@outlook.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85795-002-01Nicotine Patches30 in 1 BOXPATCH301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85795-00285795-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
ndc (package): 85795-002-01
ndc (product): 85795-002
ndc11 (package): 85795000201
spl id: 3a1abd26-c0ab-8a65-e063-6294a90ab66e
spl set id: 3a1abd26-c0aa-8a65-e063-6294a90ab66e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.