SPL v1
SPL
SPL Set ID 50a3670a-008e-09c9-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.3 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-05-26

Description

Menthol


Medication Information

Warnings and Precautions

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Indications and Usage

Wet hair in warm water, put a suitable amount onto the palm of a hand and lather well.

Clean and rinse thorougly by gently massaging hair and scalp.

Dosage and Administration

for external use only

Description

Menthol

Section 50565-1

Keep out of reach of the children

Section 51727-6

Water, Glycerin, Etc

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Menthol


Structured Label Content

Indications and Usage (34067-9)

Wet hair in warm water, put a suitable amount onto the palm of a hand and lather well.

Clean and rinse thorougly by gently massaging hair and scalp.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

Keep out of reach of the children

Section 51727-6 (51727-6)

Water, Glycerin, Etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Menthol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)