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.

Active Ingredient

Ncotine(14mg)

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

Structured Label Content

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.

Active Ingredient (55106-9)

Ncotine(14mg)

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

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

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