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| Product NDC Code | 85174-001 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 5% minoxidil topical solution |
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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 | ||||||||
| RxCUI drug identifier | 311724 | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Nanhong (Zhuhai) Biotechnology 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%
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 one mL with dropper 2 times a day directly ontothe scalp in the hair loss area using more or more often will not improve results continued use is necessary to increase and keep yourhair regrowth,or hair loss will begin again
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.ALCOHOL GLYCERIN 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.to regrow hair on the top of the scalp (vertex onlysee pictures on side of carton)
Purpose
Information about the drug product’s indications for use.Hair regrowth treatment for men
Spl product data elements
Usually a list of ingredients in a drug product.5% MINOXIDIL TOPICAL Solution MINOXIDIL GLYCERIN ALCOHOL WATER PROPYLENE GLYCOL 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.label1
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 TOPICAL SOLUTION
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 onthe side of this carton, or your hair loss is on the front ofthe scalp.5% minoxidil topical solution is not intended forfrontal baldness or receding hairline. 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 babiesand 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.May be harmful if used when pregnant or breast-feeding.Keep out of reach of children. lf swallowedget medical help or contact a Poison Control Centerright 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 hearbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occursyou do not see hair regrowth 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.do not apply on other parts of the body avoid contact with the eyes. In case of accidental contactrinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 2months with twice a day usage. For some men, you mayneed to use this product for at least 4 months before yousee 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.see hair loss pictures on side of this carton before use, read all information on carton keep the carton. lt contains important information. 5% minoxidil topical solution for men provided more hairregrowth than 2% minoxidil topical solution store at controlled room temperature 20° to 25°C(68° to 77°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.For external use only. For use by men 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