Active Ingredient
Menthol 5%
Mielle Rosemary Mintscalp Hair Strengthening Oil
FDA Label NDC 83675-034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Hanhai Trading Co., Ltd for the product Mielle Rosemary Mintscalp Hair Strengthening Oil (NDC 83675-034). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Encourage hair growth
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.
Warnings
For external use only
keep away from fire and fame
Do not use near eyes.
Keep out of reach of children.
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.
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
Keep Oot Of Reach Of Children
Keep out of reach of children.
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
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