SPL v1
SPL
SPL Set ID 2c11e412-4ed6-36be-e063-6394a90a3865
Route
TOPICAL
Published
Effective Date 2025-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Peppermint (3 g) Camphor (natural) (0.5 g)
Inactive Ingredients
Safflower Curcuma Longa Leaf Cinnamon Oil Artemisia Princeps Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-20

Description

Active ingredients (Strength)Peppermint 3g/100g Camphor 0.5g/100g

Purpose

Purpose section Promote blood circulation Anti-inflammatory effect. Relieve abdomen/back/waist coldness Regulate gastrointestinal function.


Medication Information

Purpose

Purpose section Promote blood circulation Anti-inflammatory effect. Relieve abdomen/back/waist coldness Regulate gastrointestinal function.

Description

Active ingredients (Strength)Peppermint 3g/100g Camphor 0.5g/100g

When

1. Do not apply on areas with skin redness, swelling, congestion, ulceration, or damage.

2. Not suitable for individuals with allergic tendencies.

3. Pregnant women, and children are prohibited from using it.

4. A small number of people may experience local itching or red rash during use, which is not harmful. Symptoms will gradually disappear after stopping use.

5. Skin burning sensation during use is a normal phenomenon.

6. This product is a daily household item and cannot replace medicine or medical equipment.

If discomfort occurs, stop using the product. If necessary, consult a doctor.

Package

Do Not Use

Broken or injured skin: Do not apply on broken, cut, or irritated skin.

· Pregnant women, and children are prohibited from using it.

· Sensitive skin: Perform a patch test before use if you have a history of skin allergies.

· Extended use: Avoid using for longer than recommended (10-12 hours) to prevent discomfort.

Purpose Sectio

Purpose section

Promote blood circulation

Anti-inflammatory effect.

Relieve abdomen/back/waist coldness

Regulate gastrointestinal function.

Warnings Section

lf symptoms persist, please consult your healthcare professionals. Non-GMO/Gluten Free.This product cannot replace medicine. Allergens, pregnant women, and children are prohibited from using it.

Inactive Ingredients

Mugwort Leaf Extract, Peppermint Leaf Oil, Curcuma longa, Cinnamon Extract,Safflower Extract, Camphor

Indications & Usage Section

Indications for Use:

· Relieve discomfort in the abdomen/back/waist.

· Improve Blood Circulation

· Relieve abdominal coldness and regulate gastrointestinal function.

· anti-inflammatory effect.

· Soothing Effect

Active Ingredients (strength)

Active ingredients (Strength)Peppermint 3g/100g Camphor 0.5g/100g

Dosage & Administration Section

1. Do not apply on areas with skin redness, swelling, congestion, ulceration, or damage.

2. Not suitable for individuals with allergic tendencies.

3. Pregnant women, and children are prohibited from using it.

4. A small number of people may experience local itching or red rash during use, which is not harmful. Symptoms will gradually disappear after stopping use.

5. Skin burning sensation during use is a normal phenomenon.

6. This product is a daily household item and cannot replace medicine or medical equipment.

If discomfort occurs, stop using the product. If necessary, consult a doctor.

Keep Out of Reach of Children Section

Adults only.


Structured Label Content

When (WHEN)

1. Do not apply on areas with skin redness, swelling, congestion, ulceration, or damage.

2. Not suitable for individuals with allergic tendencies.

3. Pregnant women, and children are prohibited from using it.

4. A small number of people may experience local itching or red rash during use, which is not harmful. Symptoms will gradually disappear after stopping use.

5. Skin burning sensation during use is a normal phenomenon.

6. This product is a daily household item and cannot replace medicine or medical equipment.

If discomfort occurs, stop using the product. If necessary, consult a doctor.

Package (PACKAGE)

Do Not Use (Do not use)

Broken or injured skin: Do not apply on broken, cut, or irritated skin.

· Pregnant women, and children are prohibited from using it.

· Sensitive skin: Perform a patch test before use if you have a history of skin allergies.

· Extended use: Avoid using for longer than recommended (10-12 hours) to prevent discomfort.

Purpose Sectio (Purpose sectio)

Purpose section

Promote blood circulation

Anti-inflammatory effect.

Relieve abdomen/back/waist coldness

Regulate gastrointestinal function.

Warnings Section (Warnings section)

lf symptoms persist, please consult your healthcare professionals. Non-GMO/Gluten Free.This product cannot replace medicine. Allergens, pregnant women, and children are prohibited from using it.

Inactive Ingredients (Inactive ingredients)

Mugwort Leaf Extract, Peppermint Leaf Oil, Curcuma longa, Cinnamon Extract,Safflower Extract, Camphor

Indications & Usage Section (Indications & usage section)

Indications for Use:

· Relieve discomfort in the abdomen/back/waist.

· Improve Blood Circulation

· Relieve abdominal coldness and regulate gastrointestinal function.

· anti-inflammatory effect.

· Soothing Effect

Active Ingredients (strength) (Active ingredients (Strength))

Active ingredients (Strength)Peppermint 3g/100g Camphor 0.5g/100g

Dosage & Administration Section (Dosage & administration section)

1. Do not apply on areas with skin redness, swelling, congestion, ulceration, or damage.

2. Not suitable for individuals with allergic tendencies.

3. Pregnant women, and children are prohibited from using it.

4. A small number of people may experience local itching or red rash during use, which is not harmful. Symptoms will gradually disappear after stopping use.

5. Skin burning sensation during use is a normal phenomenon.

6. This product is a daily household item and cannot replace medicine or medical equipment.

If discomfort occurs, stop using the product. If necessary, consult a doctor.

Keep Out of Reach of Children Section (keep out of reach of children section)

Adults only.


Advanced Ingredient Data


Raw Label Data

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