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Minoxidil hair regrowth solution - Medication Information

Product NDC Code 85038-007
Drug Name

Minoxidil hair regrowth solution

Type Brand
Pharm Class Arteriolar Vasodilation [PE],
Arteriolar Vasodilator [EPC]
Active Ingredients
Minoxidil 5 g/100ml
Route TOPICAL
Dosage Form SOLUTION
RxCUI drug identifier 311724
Application Number 505G(a)(3)
Labeler Name Lianjiang Shanlilai E-commerce Co., Ltd.
Packages
Package NDC Code Description
85038-007-01 1 bottle in 1 package (85038-007-01) / 60 ml in 1 bottle
85038-007-02 2 bottle in 1 package (85038-007-02) / 60 ml in 1 bottle
85038-007-03 3 bottle in 1 package (85038-007-03) / 60 ml in 1 bottle
85038-007-04 4 bottle in 1 package (85038-007-04) / 60 ml in 1 bottle
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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 onto the scalp in the hair loss area. massageinto scalp with fingers, then wash hands well. using more or more often will notimprove results. 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.
biotin 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.
Uses 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.
Minoxidil Hair Regrowth Solution Minoxidil GLYCERIN CASTOR OIL ALCOHOL CETYL ALCOHOL WATER BIOTIN MINOXIDIL MINOXIDIL 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

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.
your degree of hair loss is different than that shown on side of this carton ,because this product may not work for you. you have no family history of hair loss. your hairloss is sudden and/or patchy. your hairloss 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.
Keep out of reach of children. lfswallowed, get medical help or contact a Poison Control Centerright away.(1-800-222-1222)

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 heartbeat,faintness, or dizziness occurs. sudden, unexplained weight gain occurs. your hands or feet swel. scalp irritation or redness occurs. unwanted facial hair growth occurs. you 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 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 hair. You may need to use this product 2 times a day for at least 4 monthspefore you see results. the amount of hair regrowth is diferent for each person. This product will not work for everyone

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. 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