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| Product NDC Code | 83767-301 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 5% minoxidil hair regrowth solution 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 | SOLUTION | ||||||||
| Application Number | M032 | ||||||||
| 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 0.2%
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.Apply 1 ml of Minoxidil Serum directly onto the scalp in the hair loss area. Use fingertips to massage solution into skin/hair for 1 minutes thenwashhands thoroughly. Men: use twice daily.Women: use once daily on clean, dry hair for best results.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.CASTOR OIL ALCOHOL GLYCERIN CETYL ALCOHOL LACTIC ACID 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 of scalp and beard
Purpose
Information about the drug product’s indications for use.Hair Regrowth
Spl product data elements
Usually a list of ingredients in a drug product.5% Minoxidil Hair Regrowth Solution With Biotin Minoxidil WATER ALCOHOL LACTIC ACID MINOXIDIL MINOXIDIL BIOTIN BIOTIN CASTOR OIL GLYCERIN CETYL 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.label1 label2 label3
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 Solution 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.You have no family history of hair loss. 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.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.Ifscalp irritation or redness occurs. lf you get unwanted facial hair growth. lf you do not see hair regrowth in 4 months. lf sudden, unexplained weight gain occurs.
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 eyes. In case of accidental contact, rinse eyes with alarge amount of cool tap water. You need to use this product 1 times a day for at least 3 months beforeyou see results, The amount of hair regrowth is different for each person.
Storage and handling
Information about safe storage and handling of the drug product.Before use, read all information on carton and enclosed leaflet Storeat controlled room temperature 10° to 25°C (50° to 77°F) Do not incinerate container. Do not expose to heat or store attemperature above 104°F(40°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. Keep out of reach of children.
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