SPL v2
SPL
SPL Set ID 2969f3cc-8e45-f93d-e063-6294a90a93ad
Route
TRANSDERMAL
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (7 mg)
Inactive Ingredients
Borneol Alcohol Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Acrylic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2026-01-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Dosage and Administration

Directions

if you are under 18 years of age, ask a doctor before use.

■Before use, carefuly read the insert for complete instructions.

■lf you smoke more than 10 cigarettes per day, follow this 10-week schedule:

Step 1 Step 2

Step 3

Cigarettes per Day

Week 1(Key Adjustment Phase) Weeks 2-6 Weeks 7-8 Weeks 9-10
10-20 cigarettes two 21mg patch/day one 21mg patch/day one 14mg patch/day one 7 mg patch/day
20+ cigarettes three 21mg patch/day two 21mg patch/day one 14mg patch/day one 7 mg patch/day

■lf you smoke 10 or fewer cigarettes per day, skip STEP 1(21mg). Start with STEP 2(14mg) for 6 weeks-using two14mg patches per day for the first week, then one 14mg patch per day for weeks 2 to 6. Then move to STEP 3(7mg) for 2weeks, and stop.

Description

Drug Facts

Section 50565-1

Keep out of reach of children and pets. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center(1-800-222-1222)

Section 50567-7

When using this product

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

Section 50568-5

Ask a doctor or pharmacist before use if you are■using a non-nicotine stop smoking drug■pregnant or breast-feeding

Section 50569-3

Ask a doctor before use if you have

■heart disease ■high blood pressure ■skin allergies ■diabetes ■history of seizures

Section 51727-6

Inactive ingredients camphor, ethanol, acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Section 51945-4

Drug Facts

Section 55105-1

Stop smoking aid

Section 55106-9

Active ingredients (in each patch)

Nicotine 7mg delivered over 24 hours

Section 60561-8

Other information Store at 20-25℃ (68-77°F)


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

if you are under 18 years of age, ask a doctor before use.

■Before use, carefuly read the insert for complete instructions.

■lf you smoke more than 10 cigarettes per day, follow this 10-week schedule:

Step 1 Step 2

Step 3

Cigarettes per Day

Week 1(Key Adjustment Phase) Weeks 2-6 Weeks 7-8 Weeks 9-10
10-20 cigarettes two 21mg patch/day one 21mg patch/day one 14mg patch/day one 7 mg patch/day
20+ cigarettes three 21mg patch/day two 21mg patch/day one 14mg patch/day one 7 mg patch/day

■lf you smoke 10 or fewer cigarettes per day, skip STEP 1(21mg). Start with STEP 2(14mg) for 6 weeks-using two14mg patches per day for the first week, then one 14mg patch per day for weeks 2 to 6. Then move to STEP 3(7mg) for 2weeks, and stop.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children and pets. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center(1-800-222-1222)

Section 50567-7 (50567-7)

When using this product

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are■using a non-nicotine stop smoking drug■pregnant or breast-feeding

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■heart disease ■high blood pressure ■skin allergies ■diabetes ■history of seizures

Section 51727-6 (51727-6)

Inactive ingredients camphor, ethanol, acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Section 51945-4 (51945-4)

Drug Facts

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Active ingredients (in each patch)

Nicotine 7mg delivered over 24 hours

Section 60561-8 (60561-8)

Other information Store at 20-25℃ (68-77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)