Otc - Active Ingredient
Minoxidil 5% W/V
Biotin 0.5% W/V
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Fanyi Era Technology Co., Ltd for the product 5% Minoxidil Hair Regrowth Treatment (NDC 88028-005). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% W/V
Biotin 0.5% W/V
Hair regrowth treatment
■ Use to regrow hair on the scalp and promote beard growth for men
■ For external use only.
■ Flammable: Keep away from fire
Do not use if
■ Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
■ 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.
Ask a doctor before use if you have heart disease
When using this product
■ Do not apply on other parts of the body.
■ Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
■ Some people have experienced changes in hair color and/or texture.
■ 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.
■ The amount of hair regrowth is different for each person. This product will not work for all men.
Stop use and ask a doctor if
■ Chest pain, rapid heartbeat, faintness, or dizziness occurs.
■ Sudden, unexplained weight gain occurs.
■ Your hands or feet swell.
■ Scalp irritation or redness occurs.
■ Tunwanted facial hair growth occurs.
■ you do not see hair regrowth in 4 months.
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
■ After washing with a gentle shampoo, ensure the scalp is completely dry before application.
■ Shake well before use. Spray evenly onto affected areas twice daily, using approximately 10 sprays (1 mL) per application. Do not overuse.
■ Gently massage with fingertips until evenly distributed. Wash hands immediately with soap and water.
■ Allow to dry completely before styling hair or getting dressed.
■ For best results, use consistently for at least 4 months.
■ Before use, read all information on carton and enclosed leaflet
■ Keep the carton. It contains important information.
■ Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
■ Store at 20° to 25°C (68° to 77°F). Keep tightly closed.
Alcohol, Propylene Glycol, Panthenol, Anhydrous Citric Acid, Polysorbate 60, Carbomer Homopolymer, Unspecified Type, Water
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