87278-002 Nicotine Stop Smoking Aid

87278-002 Nicotine Stop Smoking Aid
SPL v1
SPL
SPL Set ID 45a7e1cf-7182-6ec3-e063-6394a90ae441
Route
TRANSDERMAL
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
2-hydroxyethyl Acrylate Polyethylene Powdered Cellulose Isooctyl Acrylate Silicon Dioxide Methacrylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-11
Description

Nicotine

Medication Information

Warnings and Precautions



Not for non-smokers.

Keep away from children/pets.

Consult doctor if pregnant/nursing

For external use only,flammable,keep away from heat or flame.

Indications and Usage

Helps reducewithdrawal symptoms,such as nicotine cravings,during smoking cessation

Dosage and Administration

Apply one patch to a clean, dry,and hairless area of skin (e.g.,upper arm or torso).

Replace thepatchevery24hourswithanewone.

Rotate application sites to avoid skin irritation.

Description

Nicotine

Section 50565-1

Keep away from children/pets.

Section 50566-9

OTC- Stop Use Section.If you experience severe skin irritation, rregular heartbeat, or: symptoms of nicotine overdose

(e.g., dizziness, nausea, vomiting)

Section 50567-7

When using section. Avoid smoking or using other nicotine-containing products to prevent nicotine overdose

Section 50570-1

Not for non-smokers.

Section 51727-6

2-Hydroxyethyl Acrylate

Powdered Cellulose

Methacrylic Acid

Acrylate Adhesive

Polyethylene Film

Silicone Release Liner

Section 51945-4

Section 55105-1

Stop Smoking Aid

Section 55106-9

Nicotine

Structured Label Content

Indications and Usage (34067-9)

Helps reducewithdrawal symptoms,such as nicotine cravings,during smoking cessation

Dosage and Administration (34068-7)

Apply one patch to a clean, dry,and hairless area of skin (e.g.,upper arm or torso).

Replace thepatchevery24hourswithanewone.

Rotate application sites to avoid skin irritation.

Warnings and Precautions (34071-1)



Not for non-smokers.

Keep away from children/pets.

Consult doctor if pregnant/nursing

For external use only,flammable,keep away from heat or flame.

Section 50565-1 (50565-1)

Keep away from children/pets.

Section 50566-9 (50566-9)

OTC- Stop Use Section.If you experience severe skin irritation, rregular heartbeat, or: symptoms of nicotine overdose

(e.g., dizziness, nausea, vomiting)

Section 50567-7 (50567-7)

When using section. Avoid smoking or using other nicotine-containing products to prevent nicotine overdose

Section 50570-1 (50570-1)

Not for non-smokers.

Section 51727-6 (51727-6)

2-Hydroxyethyl Acrylate

Powdered Cellulose

Methacrylic Acid

Acrylate Adhesive

Polyethylene Film

Silicone Release Liner

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop Smoking Aid

Section 55106-9 (55106-9)

Nicotine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:36.782127 · Updated: 2026-03-14T23:11:16.641314