84735-013 Nicotine Stop Smoking Aid

SPL v3

SPL

SPL Set ID 3a7feaff-e5cc-b50c-e063-6294a90ad66a

Route

TRANSDERMAL

Published

Effective Date 2025-07-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Nicotine (14 mg)

Inactive Ingredients

Methacrylic Acid 2-hydroxyethyl Acrylate Powdered Cellulose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-22

Description

Ncotine(14mg)

Medication Information

Warnings and Precautions

Not for non-smokers. Keep away from chlldrenfpets. Consult doctor if pregnant/nursing

For external use only,flammable,keep awav 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 cean, dry,and hairless area of skin (e.g.upper arm or torso).

Replace thepatchever24hourswithanewone

Rotate application sites to avoid skin irritation

Description

Ncotine(14mg)

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9

OTC- Stop Use Section lf you experience severe skin irritation, rregular heartbeat, or. svmptoms of nicotine overdose (e.g. dizziness nausea vomiting)

Section 50567-7

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

Ask Docfor, Before use if you have heart disease, high blood pressure, or.are taking prescription medication

Section 51727-6

2-Hydroxyethyl Acrlate,Powdered Cellulose, Methacrylic Acid

Section 51945-4

Section 55105-1

Stop Smoking Aid

Section 55106-9

Ncotine(14mg)

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 cean, dry,and hairless area of skin (e.g.upper arm or torso).

Replace thepatchever24hourswithanewone

Rotate application sites to avoid skin irritation

Warnings and Precautions (34071-1)

Not for non-smokers. Keep away from chlldrenfpets. Consult doctor if pregnant/nursing

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9 (50566-9)

OTC- Stop Use Section lf you experience severe skin irritation, rregular heartbeat, or. svmptoms of nicotine overdose (e.g. dizziness nausea vomiting)

Section 50567-7 (50567-7)

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

Ask Docfor, Before use if you have heart disease, high blood pressure, or.are taking prescription medication

Section 51727-6 (51727-6)

2-Hydroxyethyl Acrlate,Powdered Cellulose, Methacrylic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop Smoking Aid

Section 55106-9 (55106-9)

Ncotine(14mg)

Advanced Ingredient Data

[{"name": "METHACRYLIC ACID", "unii": "1CS02G8656", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NICOTINE", "unii": "6M3C89ZY6R", "classCode": "ACTIB", "strengthNumerator": "14", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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 cean, dry,and hairless area of skin (e.g.upper arm or torso). Replace thepatchever24hourswithanewone Rotate application sites to avoid skin irritation", "34071-1": "Not for non-smokers. Keep away from chlldrenfpets. Consult doctor if pregnant/nursing For external use only,flammable,keep awav from heat or flame.", "50565-1": "KEEP OUT OF REACH OF CHILDREN SECTION", "50566-9": "OTC- Stop Use Section lf you experience severe skin irritation, rregular heartbeat, or. svmptoms of nicotine overdose (e.g. dizziness nausea vomiting)", "50567-7": "When using sectlon, Avoid smoking or using other nicotine-containing products to prevent nicotine overdose. Ask Docfor, Before use if you have heart disease, high blood pressure, or.are taking prescription medication", "51727-6": "2-Hydroxyethyl Acrlate,Powdered Cellulose, Methacrylic Acid", "55105-1": "Stop Smoking Aid", "55106-9": "Ncotine(14mg)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:35.776767 · Updated: 2026-03-14T23:13:25.872506