83818-014

83818-014
SPL v1
SPL
SPL Set ID 36b63da9-94cc-b52a-e063-6394a90a5029
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (28 mg)
Inactive Ingredients
Archangelenone Diethylene Glycol Abietate Polyethylene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-04

Description

Nicotine: 28 mg

Purpose

stop smoking aid


Medication Information

Purpose

stop smoking aid

Description

Nicotine: 28 mg

Use

Helps reduce withdrawal symptoms, such as nicotine cravings, during smoking cessation

Stop Use

If you experience severe skin irritation, irregular heartbeat, or symptoms of nicotine overdose (e.g., dizziness, nausea, vomiting).

Warnings

Keep away from children/pets

Questions

For more information, contact VINER INC. at:

Address: 742 South Meadow St, Suite 200, Ithaca, NY 14850, USA.

Ask Doctor

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

Directions

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

Replace the patch every 24 hours with a new one.

Rotate application sites to avoid skin irritation.

Do Not Use

If you are allergic to nicotine or any adhesive patches.

If you are pregnant or breastfeeding, unless directed by a doctor.

When Using

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

Active Ingredient

Nicotine: 28 mg

Other Information

Store at room temperature (15–30°C/59–86°F).

Avoid exposure to direct sunlight or excessive heat.

Inactive Ingredients

Acrylate adhesive, polyethylene film, silicone release liner.

Principal Display Panel

Keep Out of Reach of Children

Accidental ingestion or application may cause serious harm or death.


Structured Label Content

Use

Helps reduce withdrawal symptoms, such as nicotine cravings, during smoking cessation

Purpose

stop smoking aid

Stop Use

If you experience severe skin irritation, irregular heartbeat, or symptoms of nicotine overdose (e.g., dizziness, nausea, vomiting).

Warnings

Keep away from children/pets

Questions

For more information, contact VINER INC. at:

Address: 742 South Meadow St, Suite 200, Ithaca, NY 14850, USA.

Ask Doctor

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

Directions

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

Replace the patch every 24 hours with a new one.

Rotate application sites to avoid skin irritation.

Do Not Use (Do not use)

If you are allergic to nicotine or any adhesive patches.

If you are pregnant or breastfeeding, unless directed by a doctor.

When Using

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

Active Ingredient

Nicotine: 28 mg

Other Information (Other information)

Store at room temperature (15–30°C/59–86°F).

Avoid exposure to direct sunlight or excessive heat.

Inactive Ingredients (Inactive ingredients)

Acrylate adhesive, polyethylene film, silicone release liner.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Accidental ingestion or application may cause serious harm or death.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)