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Regoxidine (for women) - Medication Information

Product NDC Code 57483-540
Drug Name

Regoxidine (for women)

Type Brand
Pharm Class Arteriolar Vasodilation [PE],
Arteriolar Vasodilator [EPC]
Active Ingredients
Minoxidil 50 mg/g
Route TOPICAL
Dosage Form AEROSOL, FOAM
RxCUI drug identifier 645146,
2264763
Application Number ANDA209074
Labeler Name Innovus Pharmaceuticals, Inc.
Packages
Package NDC Code Description
57483-540-31 2 can in 1 package (57483-540-31) / 60 g in 1 can
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Minoxidil 5% w/w (without propellant)

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 see enclosed leaflet for complete directions on how to use apply half a capful once daily directly to the scalp in the hair loss area massage into scalp with fingers, then wash hands well using more or more often will not improve 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.
Inactive ingredients butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

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 (see pictures on side of this carton)

Purpose

Information about the drug product’s indications for use.
Purpose Hair regrowth treatment for women

Spl product data elements

Usually a list of ingredients in a drug product.
Regoxidine (For Women) Minoxidil Minoxidil Minoxidil butylated hydroxytoluene cetyl alcohol anhydrous citric acid ALCOHOL isobutane LACTIC ACID, UNSPECIFIED FORM BUTANE polysorbate 60 propane WATER stearyl alcohol white to off-white foam

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.
PRINCIPAL DISPLAY PANEL - Two 60 g Can Package NDC 57483-540-31 C • rcle ™ Regoxidine ® Minoxidil Topical Aerosol, 5% (For Women) Hair Regrowth Treatment ONCE-A-DAY FOAM for Women Unscented Reactivates Hair Follicles to Stimulate Regrowth Clinically Proven to Regrow Hair #1 Dermatologist Recommended Active Ingredient † *Compare to the active ingredient of Women's Rogaine ® FOUR MONTH SUPPLY TWO 2.11 OZ (60 g) CANS PRINCIPAL DISPLAY PANEL - Two 60 g Can Package

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.
Drug Facts Distributed by: Innovus Pharmaceuticals, Inc. Englewood, CO 80112

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have heart disease

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.
Do not use if 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 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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 1-866-923-4914

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 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 6 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.
When using this product do not use more than directed 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. Results may occur at 3 months with once-daily use. For some women, you may need to use this product once a day for at least 6 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all women.

Pregnancy or breast feeding

Pregnancy or Breast feeding
May be harmful if used when pregnant or breast-feeding.

Storage and handling

Information about safe storage and handling of the drug product.
Other information see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. store at controlled room temperature 20° to 25°C (68° to 77°F) contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°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.
Warnings For external use only. Extremely Flammable Avoid fire, flame, or smoking during and immediately following application. Do not use if 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 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 Ask a doctor before use if you have heart disease When using this product do not use more than directed 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. Results may occur at 3 months with once-daily use. For some women, you may need to use this product once a day for at least 6 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all women. Stop use and ask a doctor if 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 6 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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