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.

Active Ingredient

Nicotine

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

Structured Label Content

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.

Active Ingredient (55106-9)

Nicotine

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.

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

Advanced Ingredient Data

[{"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE", "unii": "UG00KM4WR7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOOCTYL ACRYLATE", "unii": "GU1V16S82F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NICOTINE", "unii": "6M3C89ZY6R", "classCode": "ACTIB", "strengthNumerator": "21", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID", "unii": "1CS02G8656", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps reducewithdrawal symptoms,such as nicotine cravings,during smoking cessation", "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.", "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.", "50565-1": "Keep away from children/pets.", "50566-9": "OTC- Stop Use Section.If you experience severe skin irritation, rregular heartbeat, or: symptoms of nicotine overdose (e.g., dizziness, nausea, vomiting)", "50567-7": "When using section. Avoid smoking or using other nicotine-containing products to prevent nicotine overdose", "50570-1": "Not for non-smokers.", "51727-6": "2-Hydroxyethyl Acrylate Powdered Cellulose Methacrylic Acid Acrylate Adhesive Polyethylene Film Silicone Release Liner", "55105-1": "Stop Smoking Aid", "55106-9": "Nicotine"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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