SPL v1
SPL
SPL Set ID 9f26de71-3fc4-1b58-e053-2a95a90ac069
Route
TOPICAL
Published
Effective Date 2020-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-02-22

Description

L-menthol, dexpanthenol, salicylic acid


Medication Information

Warnings and Precautions

1. If skin develops abnormal symptoms or side effects such as red spots, swelling, and itching while or after using the product, or if the application area develops the symptoms above after exposure to direct sunlight, consult your dermatologist.

2. Do not apply on areas with open wounds.

3. Storage & Handling (1) Keep out of reach of children. (2) Keep away from direct sunlight.

4. If the product gets into eyes, rinse immediately with water.

5. People who have experienced allergic reactions to other products, consult a doctor or pharmacist before use.

6. Do not use on children 3 years or younger

7. Use of this product is not recommended for people who are sensitive to Salicylic Acid, people with diabetes, blood-flow disorders, renal failure, inflammation, or flare, or menstruating, pregnant, or possibly pregnant women, as they may experience oversensitive skin or extreme physical sensitivity, or a worsening of current symptoms such as abnormal skin reactions (swelling, inflammation).

Indications and Usage

Helps alleviate symptoms of hair loss

Description

L-menthol, dexpanthenol, salicylic acid

Section 50565-1

Keep Out of Reach of Children

Section 51945-4

Section 55105-1

Helps alleviate symptoms of hair loss

Section 55106-9

L-menthol, dexpanthenol, salicylic acid

Directions

hake the product before use, then evenly apply an appropriate amount on the scalp and massage the scalp with fingertips to promote absorption into the scalp. For daily use.

Inactive Ingredient

Water, Alcohol, Dipropylene Glycol, Glycerin, HouttuyniaCordata Extract, Camellia Sinensis Leaf Extract, Menthol, Panthenol, Niacinamide, Allantoin, RosmarinusOfficinalis (Rosemary) Leaf Oil, UlmusCampestris (Elm) Bark Extract, Angelica Acutiloba Root Extract, Panax Ginseng Extract, MenthaPiperita (Peppermint) Extract, Hydrolyzed Rice Protein, Tocopheryl Acetate, SesamumIndicum (Sesame) Seed Extract, Glycine Soja (Soybean) Protein, Citrus Limon (Lemon) Peel Oil, Cysteine, Methionine, PsoraleaCorylifolia Fruit Extract, Poria Cocos Extract, Butylene Glycol, AbiesSibirica Oil, Cuscuta Japonica Seed Extract, Achyranthes Japonica Extract, Nigella Sativa Seed Oil, Superoxide Dismutase, RhynchosiaNulubilis Seed Extract, RehmanniaGlutinosa Root Extract, CymbopogonSchoenanthus Oil, CynanchumWifordi Root Extract, PolygonumMultiflorum Root Extract, Hydrolyzed Collagen, TropaeolumMajus Extract, Oryza Sativa (Rice) Extract, Hydroxyethylcellulose, C11-15 Pareth-12, PEG-40 Hydrogenated Castor Oil, Salicylic Acid, Isopropyl Alcohol, Sodium Citrate


Structured Label Content

Indications and Usage (34067-9)

Helps alleviate symptoms of hair loss

Warnings and Precautions (34071-1)

1. If skin develops abnormal symptoms or side effects such as red spots, swelling, and itching while or after using the product, or if the application area develops the symptoms above after exposure to direct sunlight, consult your dermatologist.

2. Do not apply on areas with open wounds.

3. Storage & Handling (1) Keep out of reach of children. (2) Keep away from direct sunlight.

4. If the product gets into eyes, rinse immediately with water.

5. People who have experienced allergic reactions to other products, consult a doctor or pharmacist before use.

6. Do not use on children 3 years or younger

7. Use of this product is not recommended for people who are sensitive to Salicylic Acid, people with diabetes, blood-flow disorders, renal failure, inflammation, or flare, or menstruating, pregnant, or possibly pregnant women, as they may experience oversensitive skin or extreme physical sensitivity, or a worsening of current symptoms such as abnormal skin reactions (swelling, inflammation).

Section 50565-1 (50565-1)

Keep Out of Reach of Children

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps alleviate symptoms of hair loss

Section 55106-9 (55106-9)

L-menthol, dexpanthenol, salicylic acid

Directions

hake the product before use, then evenly apply an appropriate amount on the scalp and massage the scalp with fingertips to promote absorption into the scalp. For daily use.

Inactive Ingredient (INACTIVE INGREDIENT)

Water, Alcohol, Dipropylene Glycol, Glycerin, HouttuyniaCordata Extract, Camellia Sinensis Leaf Extract, Menthol, Panthenol, Niacinamide, Allantoin, RosmarinusOfficinalis (Rosemary) Leaf Oil, UlmusCampestris (Elm) Bark Extract, Angelica Acutiloba Root Extract, Panax Ginseng Extract, MenthaPiperita (Peppermint) Extract, Hydrolyzed Rice Protein, Tocopheryl Acetate, SesamumIndicum (Sesame) Seed Extract, Glycine Soja (Soybean) Protein, Citrus Limon (Lemon) Peel Oil, Cysteine, Methionine, PsoraleaCorylifolia Fruit Extract, Poria Cocos Extract, Butylene Glycol, AbiesSibirica Oil, Cuscuta Japonica Seed Extract, Achyranthes Japonica Extract, Nigella Sativa Seed Oil, Superoxide Dismutase, RhynchosiaNulubilis Seed Extract, RehmanniaGlutinosa Root Extract, CymbopogonSchoenanthus Oil, CynanchumWifordi Root Extract, PolygonumMultiflorum Root Extract, Hydrolyzed Collagen, TropaeolumMajus Extract, Oryza Sativa (Rice) Extract, Hydroxyethylcellulose, C11-15 Pareth-12, PEG-40 Hydrogenated Castor Oil, Salicylic Acid, Isopropyl Alcohol, Sodium Citrate


Advanced Ingredient Data


Raw Label Data

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