87278-001 Guhio Nicotine Patch

87278-001 Guhio Nicotine Patch
SPL v1
SPL
SPL Set ID 45a53cd6-3e3f-697a-e063-6394a90a6c83
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
Powdered Cellulose 2-hydroxyethyl Acrylate 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. Consult doctor if pregnant/nursing

Section 50566-9

OTC- Stop Use Section.lf you experience severe skin iritation, 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

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

Section 50570-1

Not for non-smokers.

Section 51727-6

2-Hydroxyethyl Acrylate, Powdered Cellulose, Methacrylic Acid

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. Consult doctor if pregnant/nursing

Section 50566-9 (50566-9)

OTC- Stop Use Section.lf you experience severe skin iritation, 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

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

Section 50570-1 (50570-1)

Not for non-smokers.

Section 51727-6 (51727-6)

2-Hydroxyethyl Acrylate, Powdered Cellulose, Methacrylic Acid

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)