SPL v1
SPL
SPL Set ID 49461c52-e276-56f6-e063-6294a90aa56a
Route
TOPICAL
Published
Effective Date 2026-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anthemis Nobilis Flower Oil (0.015 mg) Eugenia Caryophyllus (clove) Flower Oil (0.3 mg) Zingiber Officinale (ginger) Root Oil (29.655 mg)
Inactive Ingredients
Glycerin Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-26

Description

ANTHEMIS NOBILIS FLOWER OIL、EUGENIA CARYOPHYLLUS (CLOVE) FLOWER OIL、ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT


Medication Information

Warnings and Precautions

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Indications and Usage

1. Remove the patch from packaging, hold by the corner and remove the backing.

2.Place the patch on a dry hairless area of skin like the thigh, shoulder back or upper buttocks.

3.To remove, wet the patch with warm water & gently pull each corner & peel inward.

Dosage and Administration

1. Remove the patch from packaging, hold by the corner and remove the backing.

2.Place the patch on a dry hairless area of skin like the thigh, shoulder back or upper buttocks.

3.To remove, wet the patch with warm water & gently pull each corner & peel inward.

Description

ANTHEMIS NOBILIS FLOWER OIL、EUGENIA CARYOPHYLLUS (CLOVE) FLOWER OIL、ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

1. Remove the patch from packaging, hold by the corner and remove the backing.

2.Place the patch on a dry hairless area of skin like the thigh, shoulder back or upper buttocks.

3.To remove, wet the patch with warm water & gently pull each corner & peel inward.

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

AQUA、GLYCERIN

Section 51945-4

Section 55105-1

1. Through slow-release penetration, the active ingredients are gradually released, which effectively helps relieve fatigue caused by quitting smoking, restores physical vitality, and promotes overall health. 2. Designed specifically for quitting smoking, it helps alleviate the discomfort caused by quitting smoking, relaxes the body and mind, and improves the success rate of quitting smoking. 3. Help the body gradually adapt to a smoke-free life and promote a healthy lifestyle.

Section 55106-9

ANTHEMIS NOBILIS FLOWER OIL、EUGENIA CARYOPHYLLUS (CLOVE) FLOWER OIL、ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT


Structured Label Content

Indications and Usage (34067-9)

1. Remove the patch from packaging, hold by the corner and remove the backing.

2.Place the patch on a dry hairless area of skin like the thigh, shoulder back or upper buttocks.

3.To remove, wet the patch with warm water & gently pull each corner & peel inward.

Dosage and Administration (34068-7)

1. Remove the patch from packaging, hold by the corner and remove the backing.

2.Place the patch on a dry hairless area of skin like the thigh, shoulder back or upper buttocks.

3.To remove, wet the patch with warm water & gently pull each corner & peel inward.

Warnings and Precautions (34071-1)

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 50566-9 (50566-9)

Discontinue use if signs of irritation or rash occur.

Section 50567-7 (50567-7)

1. Remove the patch from packaging, hold by the corner and remove the backing.

2.Place the patch on a dry hairless area of skin like the thigh, shoulder back or upper buttocks.

3.To remove, wet the patch with warm water & gently pull each corner & peel inward.

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

AQUA、GLYCERIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. Through slow-release penetration, the active ingredients are gradually released, which effectively helps relieve fatigue caused by quitting smoking, restores physical vitality, and promotes overall health. 2. Designed specifically for quitting smoking, it helps alleviate the discomfort caused by quitting smoking, relaxes the body and mind, and improves the success rate of quitting smoking. 3. Help the body gradually adapt to a smoke-free life and promote a healthy lifestyle.

Section 55106-9 (55106-9)

ANTHEMIS NOBILIS FLOWER OIL、EUGENIA CARYOPHYLLUS (CLOVE) FLOWER OIL、ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)