Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f469f1d3-adc1-a719-e053-2995a90ad08a
Route
TOPICAL
Published
Effective Date 2023-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexpanthenol (0.2 g) Levomenthol (0.3 g) Salicylic Acid (0.25 g)
Inactive Ingredients
Butylene Glycol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-02-11

Description

-menthol, Salicylic acid, Dexpanthenol


Medication Information

Warnings and Precautions

1) After application, if there are any abnormal symptoms or side effects such as red spots, swelling, or itching in the area from direct sunlight, please consult with a specialist.

2) Avoid using the product on areas with scarring or open wounds.

3) Storage and handling

A) Keep out of reach of children

B) Keep away from direct sunlight

4) Keep out of eyes, if this occurs, rinse immediately with water

5) For any adverse allergic reactions, please consult your doctor or pharmacist before use.

6) Not for children under the age of 3

7) Those with diabetes, blood circulation disorder, renal failure, infection, redness, hypersensitivity to salicylic acid, etc., and those who are pregnant or likely to become pregnant may experience skin or body hypersensitivity or skin adverse reactions (edema, inflammation, etc.). Avoid using the product if symptoms arise

Indications and Usage

Shake the product thoroughly, then apply evenly onto the scalp with the massage roller.

Dosage and Administration

external use only

Description

-menthol, Salicylic acid, Dexpanthenol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Alcohol

PEG-60 Hydrogenated Castor Oil

Trideceth-10

Fragrance

Butylene Glycol

1,2-Hexanediol

Caprylyl Glycol

Tromethamine

Ginkgo Biloba Leaf Extract

Sophora Flavescens Extract

Urtica Dioica (Nettle) Extract

Carthamus Tinctorius (Safflower) Flower Extract

Brassica Oleracea Italica Extract

Carbomer

Pueraria Lobata Root Extract

Illicium Verum (Anise) Fruit Extract

Sodium Hyaluronate

Section 51945-4

Section 55105-1

Helps treat hair loss symptoms

Section 55106-9

-menthol, Salicylic acid, Dexpanthenol


Structured Label Content

Indications and Usage (34067-9)

Shake the product thoroughly, then apply evenly onto the scalp with the massage roller.

Dosage and Administration (34068-7)

external use only

Warnings and Precautions (34071-1)

1) After application, if there are any abnormal symptoms or side effects such as red spots, swelling, or itching in the area from direct sunlight, please consult with a specialist.

2) Avoid using the product on areas with scarring or open wounds.

3) Storage and handling

A) Keep out of reach of children

B) Keep away from direct sunlight

4) Keep out of eyes, if this occurs, rinse immediately with water

5) For any adverse allergic reactions, please consult your doctor or pharmacist before use.

6) Not for children under the age of 3

7) Those with diabetes, blood circulation disorder, renal failure, infection, redness, hypersensitivity to salicylic acid, etc., and those who are pregnant or likely to become pregnant may experience skin or body hypersensitivity or skin adverse reactions (edema, inflammation, etc.). Avoid using the product if symptoms arise

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Alcohol

PEG-60 Hydrogenated Castor Oil

Trideceth-10

Fragrance

Butylene Glycol

1,2-Hexanediol

Caprylyl Glycol

Tromethamine

Ginkgo Biloba Leaf Extract

Sophora Flavescens Extract

Urtica Dioica (Nettle) Extract

Carthamus Tinctorius (Safflower) Flower Extract

Brassica Oleracea Italica Extract

Carbomer

Pueraria Lobata Root Extract

Illicium Verum (Anise) Fruit Extract

Sodium Hyaluronate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps treat hair loss symptoms

Section 55106-9 (55106-9)

-menthol, Salicylic acid, Dexpanthenol


Advanced Ingredient Data


Raw Label Data

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