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| Product NDC Code | 83565-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Le phoqua hair regrowth serum biotin 5% minoxidil |
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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 | 505G(a)(3) | ||||
| Labeler Name | Stellans Inc. | ||||
| 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 Minoxidil 5% w/v............Hair Regrowth Treatment
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 1. Apply 1 ml with dropper2 times a day directly onto the scalp in the hair loss area. 2. Using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again. check grammar
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alcohol Propylene Glycol Purified 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 Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Purpose
Information about the drug product’s indications for use.Purpose Hair Regrowth Treatment
Spl product data elements
Usually a list of ingredients in a drug product.LE PHOQUA Hair Regrowth Serum BIOTIN 5% MINOXIDIL Hair Regrowth Serum PROPYLENE GLYCOL MINOXIDIL MINOXIDIL WATER ALCOHOL
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.PRINCIPAL DISPLAY PANEL 1
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. ·Your scalp is red.
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 Oot Of Reach Of Children Do not place this product within the reach of children
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions CONTACT US www.lephoqua.com [email protected]
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 irritation or redness occurs ·Unwanted fa cial 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information *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 minoxidill topical solution 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 solution 2% *Store at 20°to 25℃(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. ·Flammable: 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