83675-034

83675-034
SPL v1
SPL
SPL Set ID 1090b061-26ab-262e-e063-6394a90a27d4
Route
topical
Published
Effective Date 2024-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (5 g)
Inactive Ingredients
soybean oil castor oil coconut oil equisetum arvense top pogostemon cablin leaf oil silicon dioxide rice bran oil glycerin ocimum gratissimum leaf oil vitamin a palmitate ascorbic acid 1-chloronaphthalene urtica dioica leaf almond oil .alpha.-tocopherol acetate biotin arctium lappa root oil safflower oil isotachysterol 3 aloe vera flower sage oil rosemary oil mentha piperita leaf jojoba oil eucalyptus globulus leaf tea tree oil lavender oil wheat germ oil evening primrose oil grape seed oil benzyl nicotinate celery seed

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-03

Purpose

Encourage hair growth

Description

Menthol 5%


Medication Information

Warnings

For external use only

keep away from fire and fame

Do not use near eyes.

Keep out of reach of children.

Purpose

Encourage hair growth

Directions

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.

using more or more often will not improve resultsApply a small amount of oil to scalp, massage oil in ith fingers and comb through to ends of hair. Leave n and style as desired.Daily Use: Apply a small amunt to scalp and comb through to ends, Split End Cre: Apply oil to ends of hair, place a processing cap (n head and leave on for 10 minutes. Rinse and proced with shampooing.

Inactive Ingredients

Glycine Soja (Soybean) Oil, Ricinus Communis (Castpr)Seed Oil,Rosmarinus Ofhcinalis (Rosemary)Leaf Oil,Simmondsia Chinensis (Jojoba) Seed Oil, Mentha Piperita (Peppermint) Oil, Eucalvptus Globolus (Euc alyptus)Leaf Oil, Menthol, Melalueca Alternifolia(Te a Tree)Leaf Oil,Cocos Nucifera (Coconut) Oil,Equise tum Arvense(Horsetail)Extract,Aloe Barbadensis Ext ract,Lavandula Angustifolia (Lavender) Oil, Triticum Vulgare (Wheat)Germ Oil, Carthamus Tinctorius (Safflower) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Vitis Vinifera (Grape) Seed

Description

Menthol 5%

Principal Display Panel

Use

Help you solve hair problems. From nourishing hair follicles, smoothing split ends, to helping dry the scalp, this hair oil uses natural organic ingredients and essential oils to provide the necessary care for your hair. Use it for protective styles, including braids and braids, and enjoy its fresh and vibrant fragrance during the next hot oil treatment.

Stop Use

• chest pain, rapid heartbeat, faintness, or dizziness occurs

• sudden, unexplained weight gain occurs

• your hands or feet swell

• scalp irritation or redness occurs

• unwanted facial hair growth occurs

Ask Doctor

When Pregnant or breast-feeding

Do Not Use

• you have no family history of hair loss

• your hair loss is sudden and/or patchy

• you do not know the reason for your hair loss

• you are under 18 years of age. Do not use on babies and children

• your scalp is red, inflamed, infected, irritated or painful

• you use other medicines on the scalp

When Using

it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.

Active Ingredient

Menthol 5%

Keep Oot of Reach of Children

Keep out of reach of children.


Structured Label Content

Warnings

For external use only

keep away from fire and fame

Do not use near eyes.

Keep out of reach of children.

Purpose

Encourage hair growth

Directions

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.

using more or more often will not improve resultsApply a small amount of oil to scalp, massage oil in ith fingers and comb through to ends of hair. Leave n and style as desired.Daily Use: Apply a small amunt to scalp and comb through to ends, Split End Cre: Apply oil to ends of hair, place a processing cap (n head and leave on for 10 minutes. Rinse and proced with shampooing.

Inactive Ingredients (Inactive ingredients)

Glycine Soja (Soybean) Oil, Ricinus Communis (Castpr)Seed Oil,Rosmarinus Ofhcinalis (Rosemary)Leaf Oil,Simmondsia Chinensis (Jojoba) Seed Oil, Mentha Piperita (Peppermint) Oil, Eucalvptus Globolus (Euc alyptus)Leaf Oil, Menthol, Melalueca Alternifolia(Te a Tree)Leaf Oil,Cocos Nucifera (Coconut) Oil,Equise tum Arvense(Horsetail)Extract,Aloe Barbadensis Ext ract,Lavandula Angustifolia (Lavender) Oil, Triticum Vulgare (Wheat)Germ Oil, Carthamus Tinctorius (Safflower) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Vitis Vinifera (Grape) Seed

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

Help you solve hair problems. From nourishing hair follicles, smoothing split ends, to helping dry the scalp, this hair oil uses natural organic ingredients and essential oils to provide the necessary care for your hair. Use it for protective styles, including braids and braids, and enjoy its fresh and vibrant fragrance during the next hot oil treatment.

Stop Use

• chest pain, rapid heartbeat, faintness, or dizziness occurs

• sudden, unexplained weight gain occurs

• your hands or feet swell

• scalp irritation or redness occurs

• unwanted facial hair growth occurs

Ask Doctor

When Pregnant or breast-feeding

Do Not Use (Do not use)

• you have no family history of hair loss

• your hair loss is sudden and/or patchy

• you do not know the reason for your hair loss

• you are under 18 years of age. Do not use on babies and children

• your scalp is red, inflamed, infected, irritated or painful

• you use other medicines on the scalp

When Using

it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.

Active Ingredient

Menthol 5%

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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