85795-002

85795-002
SPL v1
SPL
SPL Set ID 3a1abd26-c0aa-8a65-e063-6294a90ab66e
Route
TOPICAL
Published
Effective Date 2025-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Acrylic Acid Camphor, (-)- Aluminum Powder Methacrylic Acid Alcohol Powdered Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

Nicotine 21mg

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine 21mg

Use

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

Stop Use

if irritation or allergic reactions occur

Warnings

For external use only

Questions

Contactus at:[email protected]

Ask Doctor

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

Directions

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.

Do Not Use

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

When Using

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

Active Ingredient

Nicotine 21mg

Other Information

Store at 20-25°℃(68-77°F)

Inactive Ingredients

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

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

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

Purpose

Stop smoking aid

Stop Use

if irritation or allergic reactions occur

Warnings

For external use only

Questions

Contactus at:[email protected]

Ask Doctor

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

Directions

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.

Do Not Use (Do not use)

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

When Using

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

Active Ingredient

Nicotine 21mg

Other Information (Other information)

Store at 20-25°℃(68-77°F)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)