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| Product NDC Code | 83767-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | 5% minoxidil hair regrowth foam |
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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 | Guangzhou Ruijiu Electronic 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.See enclosed leallet for complete directions on howr to use. Apply half a capful twice daily directly to the scalp in the hair lossаrea. Massage into scalp with fingers, then wash hands well. Using more or more often will not improve results. Continued use is necessary to increase and keep your hair regrowthor hair loss will begin again.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.ALCOHOL GLYCERIN CETYL ALCOHOL STEARYL ALCOHOL POLYSORBATE 80 ANHYDROUS CITRIC ACID LACTIC ACID CASTOR OIL .ALPHA.-TOCOPHEROL EDETATE DISODIUM WATER
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 on the top 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 Regrowth Foam Minoxidil .ALPHA.-TOCOPHEROL GLYCERIN POLYSORBATE 80 ANHYDROUS CITRIC ACID BIOTIN BIOTIN STEARYL ALCOHOL CETYL ALCOHOL ALCOHOL WATER EDETATE DISODIUM MINOXIDIL MINOXIDIL CASTOR OIL LACTIC ACID
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 Regrowth Foam
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.you are a woman. your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front ofthe scalp. 5% minoxidilfoam 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 knoww the reason foryour hair loss. You are under 18 years of age. Do not use on babies and children. You use other medicines on the scalp. Your scalp is red, inflamed, infected, irritated, or painful
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.If swallowed, get medical help or contact a Poison ControlCenter right away,(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.if chest pain, rapid heartbeat, faintness, or dizziness occurs. if sudden, unexplained weight gain occurs. if your hands or feet swell. if scalp irritation or redness occurs. if unwanted facial hair growth occurs. if 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.Do not apply on other parts ofthe body. Avoid contact with the eyes, in case of accidental contact, rinseeyes with large amounts of cool tap water. Some people have experienced changes in hair color and/or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage, For some men, you may need to use this productfor at least 6 months before you see results. The amount of hair regrowth is different for each person.This product will not work for all men.
Storage and handling
Information about safe storage and handling of the drug product.Before use, read all information on carton and enclosed leaflet .Store at controlled room temperature 20° to 25°C (68° to 77°F)Do not incinerate container, Do not expose to heat or store attemperature abowe 120°F (49°C].
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.For external use only. For use by men only. Extremely Flammable:Avoid fire, flame, or smoking during andimmediately following application.
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