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Product NDC Code | 83767-101 | ||||
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Drug Name | Ruigoo minoxidil topical gel |
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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 | GEL | ||||
RxCUI drug identifier | 2668433 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Guangzhou Ruijiu Electronic Technology Co., Ltd. | ||||
Packages |
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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 1ml once daily, gently massaging to enhance absorption.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.STEARIC ACID OLEIC ACID POLYSORBATE 80 SORBITAN MONOOLEATE CARBOMER HOMOPOLYMER CETYL ALCOHOL CITRIC ACID MONOHYDRATE GLYCERIN 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.is for Women who have a general thinning of hair onthe top of the scalp as shown.
Purpose
Information about the drug product’s indications for use.Hair regrowth treatment for women. Use to regrow hair on the top of the scalp.
Spl product data elements
Usually a list of ingredients in a drug product.Ruigoo Minoxidil Topical Gel MINOXIDIL 5% CETYL ALCOHOL GLYCERIN POLYSORBATE 80 STEARIC ACID SORBITAN MONOOLEATE OLEIC ACID CITRIC ACID MONOHYDRATE MINOXIDIL MINOXIDIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER
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
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.RUIGOO MINOXIDIL TOPICAL GEL
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 cartonbecause this product may not work for you. Your hair loss is sudden and/or patchy You are under 18 years of age. Do not use on babies or 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. lf swallowed, get medical help orcontact a Poison Control Center right 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.Stop use and ask a doctor if you experience chest pain, rapidheartbeat, faintness, or dizziness occurs, Scalp irritation or redness occurs.These may be signs of a serious condition.
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 use more than directed. Avoid contact with the eyes, ears, and mouth. In case of accidental contact, rinse eyes with large amounts of cool tap water. lt takes time to regrow hair. Results may occur at 2 months with once dailyuse. For some individuals, it may take at least 4 months before resultsbecome noticeable. The amount of hair regrowth is different for each person. This product will not work for all women.
Storage and handling
Information about safe storage and handling of the drug product.Store between 41-86 ℉ (5-30 ℃). Avoid freezing and exposure to excessiveheat above 104 ℉ (40 ℃)
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.
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