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| Product NDC Code | 84232-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Hair regen hair growth treatment |
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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 | LIQUID | ||||
| RxCUI drug identifier | 311724 | ||||
| Application Number | M016 | ||||
| Labeler Name | YIWUYIZHOUTRADINGCO.,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.Active Ingredient(s) Minoxidil 5% w/v
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.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 resufts. ●continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients
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 top of scalp (vertex only, see pictures on side of box)
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Hair Regen Hair Growth Treatment Minoxidil ALCOHOL PROPYLENE GLYCOL WATER MINOXIDIL MINOXIDIL
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.Package Label - Principal Display Panel Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.RECENT
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.Do not use You are a woman. 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, rritated, 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. If swallowed, get medical help or contact a Poison Control Center 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.Stop use ●Chest pain, rapid heartbeat, faintness, or dizziness occurs ●Sudden, unexplained weight gain occurs ●Your hands or feet swell ●Scalp rritation or redness ocurs ●Unwanted facial hair growth occurs ●You do not see hair growth in 4 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.When using this product. ●Do not apply on other parts of your body. ●Avoid contact with the eyes. In case 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 hai, 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 on all men,
Storage and handling
Information about safe storage and handling of the drug product.Other information ●See hair loss pictures on side of box ●Before use, read all information on box and enclosed instructions. ●Keep the box, 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 sol ution 5% for men. ●In Clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical sol lution 2% ●Store at 20° to 25*C (68° to 77*F). Keep tightly closed
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.Warnings For external use only. For use by men only.FI ammable: Keep away from fire or flame
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