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| Product NDC Code | 83766-103 | ||||
|---|---|---|---|---|---|
| Drug Name | 5% minoxidil hair growth foam with biotin |
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| Type | Brand | ||||
| Pharm Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Shenzhen Joyuflsh Technology Co.,Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Minoxidil 5% Biotin 0.5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.1.Hold the bottle upside down and gently press the valve to dispense foam onto your hand or a cold surfaceapproximately half a capful in size 2.Massage the foam into your scalp with your fingers, parting your hair into rows to ensure even applicationto areas of thinning hair. Finally, wash your hands thoroughly. 3.Use Twice Daily and enjoy thicker, fuller hair growth in as little as 3 to 6 months
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.cetyl alcohol citric acid glycerin isobutane lactic acid polysorbate 60 purified water SD ALCOHOL stearyl alcohol butane edetate disodium
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use to regrow hair of the scalp
Purpose
Information about the drug product’s indications for use.Hair Regrowth Treatment
Spl product data elements
Usually a list of ingredients in a drug product.5% Minoxidil Hair Growth Foam with Biotin Minoxidil BIOTIN BIOTIN MINOXIDIL MINOXIDIL CETYL ALCOHOL CITRIC ACID LACTIC ACID STEARYL ALCOHOL BUTANE GLYCERIN POLYSORBATE 60 ALCOHOL WATER EDETATE DISODIUM ISOBUTANE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.5% Minoxidil Hair Growth Foam with Biotin
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Your hair loss is sudden and/or patchy. Your hair loss is associated with childbirth. 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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children .lf swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs. lf unwanted facial hair growth occurs . lf you do not see hair regrowth in 6 months.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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. lt takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, youmay need to use this product for at least 6 months before you see results. The amount of hair regrowth isdifferent for each person. Avoid contact with eyes. in case of accidental contact, rinse eves with a large amount of cool tap water
Storage and handling
Information about safe storage and handling of the drug product.Before use, read all information on the carton and the enclosed leaflet.Store at a controlled room temperature of 20'C to 25°C (68°F to 77°F)Do not incinerate the container. Do not expose it to heat or store it at temperatures above 40'C (104°F).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Flammable:keep away from fire or flame. Keep out of reach of children. For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API