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| Product NDC Code | 25280-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Loesch hair regrowth formula unscented topical solution regular-strength for men and women |
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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 | 311723 | ||||
| Application Number | ANDA075357 | ||||
| Labeler Name | Loesch Laboratory Consultant, 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 Ingredients Minoxidil 2% w/v
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 Apply one mL 2 times daily directly onto the scalp in the hair loss area. Using more or more often will not improve results. Continued use is necessary or hair loss will resume.
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 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.Loesch Hair Regrowth Formula Unscented Topical Solution Regular-Strength for Men and Women minoxidil MINOXIDIL MINOXIDIL WATER PROPYLENE GLYCOL 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.2% Minoxidil 2% Minoxidil box
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 If swallowed, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information See hair loss picture on the side of this carton. Before use, read all information on carton and printed insert. 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 Minoxidil Topical Solution 2%. In clinical studies with mostly caucasian women aged 18-45 years with mild to no moderate degrees of hair loss, the following respone to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using Minoxidil Topical Solution 2% for 8 months. This compares with 7% of women reporting moderate hair regrowth and 33% reporting minimal regrowth after using the placebo, the liquid without minoxidil in it, for 8 months.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-800-237-7157
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.
Do not use if 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 2% 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. Do not use on babies or children. Your scalp is red, inflamed, infected, irritated, or painful. You use other medicines on the scalp.
ASK DOCTOR Ask a doctor before use if you have heart disease.
When using this 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. Results may occur at 2 months with twice daily usage. For some men, you may need to use this product for at least 4 months before you see results. The amount of hair regrowth is different for each person. This product will not work for everyone.
Stop use and ask a doctor if you have Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs. Your hands or feet swell. Scalp irritation or redness occurs. Unwanted facial hair growth occurs. You do not see hair regrowth in 4 months.
Pregnancy or breast feeding May be harmful if used when pregnant or breast-feeding.
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