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| Product NDC Code | 58602-607 | ||||||||||||
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| Drug Name | Minoxidil 5% (for 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 | AEROSOL, FOAM | ||||||||||||
| Application Number | ANDA218616 | ||||||||||||
| Labeler Name | Aurohealth LLC | ||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Minoxidil USP 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 booklet 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 Alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol Questions? Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/58039/2020
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.MINOXIDIL 5% (FOR WOMEN) MINOXIDIL MINOXIDIL MINOXIDIL ALCOHOL ANHYDROUS CITRIC ACID BUTANE BUTYLATED HYDROXYTOLUENE CETYL ALCOHOL GLYCERIN ISOBUTANE LACTIC ACID, UNSPECIFIED FORM POLYSORBATE 60 PROPANE WATER STEARYL 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.PRINCIPAL DISPLAY PANEL - One 60 g Can Label AUROHEALTH NDC 58602-607-01 Minoxidil Topical Aerosol 5% (FOR WOMEN) HAIR REGROWTH TREATMENT REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH CLINICALLY PROVEN TO REGROW HAIR Once-a-Day Foam For Women UNSCENTED Two Month Supply One 60 g (2.11 OZ) Can fig
PRINCIPAL DISPLAY PANEL - One 60 g Can Carton AUROHEALTH NDC 58602-607-01 * Compare to the active ingredient of Women's Rogaine ® Minoxidil Topical Aerosol 5% (FOR WOMEN) HAIR REGROWTH TREATMENT REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH Once-a-Day Foam For Women CLINICALLY PROVEN TO REGROW HAIR UNSCENTED TWO MONTH SUPPLY ONE 60 g (2.11 OZ) CAN fig
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
IMPORTANT INFORMATION ABOUT Minoxidil Topical Aerosol 5% (For Women) Hair Regrowth Treatment REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH CLINICALLY PROVEN TO REGROW HAIR Once – a-Day Foam For Women UNSCENTED Minoxidil Topical Aerosol 5% (For Women) Hair Regrowth Treatment Save this booklet for future reference. Please read this booklet carefully. It will help you understand how to use Women’s Minoxidil Topical Aerosol 5% (Foam) and what to expect from its use. It takes time to regrow hair. Results may occur at 3 months with once daily usage. For some women, you may needed to use this product for at least 6 months before you see results. If you have any questions after reading this booklet, or anytime while using Women’s Minoxidil Topical Aerosol 5% (Foam), you should ask your health care professional or call us at toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST). WHAT IS WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? Women’s Minoxidil Topical Aerosol 5% (Foam) is a white foam containing 5% minoxidil for use only on the scalp to help regrow hair in women. WHO MAY USE WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? Women’s Minoxidil Topical Aerosol 5% (Foam) may be appropriate for you if you are an adult who is at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the scalp. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss. Women’s Minoxidil Topical Aerosol 5% (Foam) is for general thinning of hair on the top of the scalp as shown on the next page. Women’s Minoxidil Topical Aerosol 5% (Foam) has been shown to regrow hair in women with the degrees of hair loss shown. If women have more hair loss than shown, Women’s Minoxidil Topical Aerosol 5% (Foam) may not work. Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If there is no family history of gradual thinning or gradual hair loss, or hair loss is patchy, see your doctor. WHO SHOULD NOT USE WOMEN’S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? Women’s Minoxidil Topical Aerosol 5% (Foam) will not prevent or improve hair loss related to pregnancy, the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; excessive vitamin A intake), the recently discontinued use of birth control pills, low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, Women’s Minoxidil Topical Aerosol 5% (Foam) will not improve hair loss due to: Damage from the use of hair care products which cause scarring or deep burns of the scalp. Hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp. Do not use if you are not sure of the reason for your hair loss. WILL WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) WORK FOR ME? The amount of hair regrowth is different for each person. Not everyone will respond to Women’s Minoxidil Topical Aerosol 5% (Foam). The response to Women’s Minoxidil Topical Aerosol 5% (Foam) cannot be predicted. No one will be able to grow back all their hair. To see your best results with Women’s Minoxidil Topical Aerosol 5% (Foam), make sure you apply the product directly to the scalp once daily . For some Women’s Minoxidil Topical Aerosol 5% (Foam) may not work. HOW SOON CAN I EXPECT RESULTS FROM USING WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with Women’s Minoxidil Topical Aerosol 5% (Foam) also takes time. Generally, new hair growth is slow for a Women’s Minoxidil Topical Aerosol 5% (Foam) user. Results may be seen as early as 3 months with once daily use. For some women, it may take at least 6 months for results to be seen. If you do not see any results after 6 months, stop using Women’s Minoxidil Topical Aerosol 5% (Foam) and seek the advice of your doctor. When you first begin to use Women’s Minoxidil Topical Aerosol 5% (Foam), your hair loss may continue for up to 2 weeks. This increase in hair loss is expected and is temporary. However, if it continues after two weeks, see your physician. IF WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) IS WORKING, WHAT WILL THE HAIR LOOK LIKE? At first, hair growth may be soft, downy, and colorless hairs. After further use, the new hairs should be the same color and thickness as the other hairs on your scalp. HOW LONG DO I NEED TO USE WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? If you respond to Women’s Minoxidil Topical Aerosol 5% (Foam), you need to use it once daily to keep and continue the hair regrowth. Up to 3 months of usage may be needed to see your best results from Women’s Minoxidil Topical Aerosol 5% (Foam). WHAT HAPPENS IF I COMPLETELY STOP USING WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? WILL I KEEP THE NEW HAIR? Continuous use of Women’s Minoxidil Topical Aerosol 5% (Foam) is needed to maintain hair regrowth. If you stop using Women’s Minoxidil Topical Aerosol 5% (Foam), the normal hair loss process will start again. You will probably lose your newly regrown hair in three to four months. HOW DO I USE WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? For best results, apply half a capful once a day directly to the scalp in the hair loss area. Using more than the recommended amount will not improve results. Each can should last two months, if used as directed. Never take this product by mouth or apply to other parts of the body. Please refer to the “Directions for Use” section of this booklet. WHEN DO I USE WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? Apply Women’s Minoxidil Topical Aerosol 5% (Foam) once daily . If you apply at night, allow application to dry completely before going to bed. WHAT IF I FORGET TO USE WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) OR MISS A DOSE? If you miss one daily doses of Women’s Minoxidil Topical Aerosol 5% (Foam), just continue with your next dose. You should not make up for missed doses. CAN I USE WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) MORE THAN ONCE A DAY? WILL IT WORK FASTER, BETTER? No. Women’s Minoxidil Topical Aerosol 5% (Foam) will not work faster or better if used more than once a day . More frequent use or larger doses have not been shown to speed up hair growth and may increase your chance of side effects. WHAT KIND OF SHAMPOO SHOULD I USE WITH WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? If you wash your scalp before applying Women’s Minoxidil Topical Aerosol 5% (Foam), use a mild shampoo. CAN I USE HAIR SPRAYS , MOUSSES , CONDITIONERS , GELS , ETC.? Yes. There is no reason to change your usual hair care routine when using Women’s Minoxidil Topical Aerosol 5% (Foam). However, you should apply Women’s Minoxidil Topical Aerosol 5% (Foam) first and wait for it to dry before applying your styling aids. CAN I HAVE MY HAIR COLORED OR PERMED OR USE HAIR RELAXERS WHILE USING WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? Yes. We have no evidence that coloring or perming, or using relaxers on your hair change the effect of Women’s Minoxidil Topical Aerosol 5% (Foam). However, because the use of a permanent wave and hair color can cause scalp irritation on certain people, we recommend the following precautions: To avoid possible scalp irritation, you should make sure all of the Women’s Minoxidil Topical Aerosol 5% (Foam) has been washed off the hair and scalp before using color or perm chemicals. For best results, do not apply Women’s Minoxidil Topical Aerosol 5% (Foam) on the same day that you use a chemical treatment on your hair. Do not use Women’s Minoxidil Topical Aerosol 5% (Foam) for 24 hours after using any chemicals to make sure your scalp has not been irritated by the perm or color treatment. If no irritation occurs, continue use of Women’s Minoxidil Topical Aerosol 5% (Foam) as usual. Simply restart your normal Women’s Minoxidil Topical Aerosol 5% (Foam) routine. There is no need to use more Women’s Minoxidil Topical Aerosol 5% (Foam) to make up for missed applications. Missing one day of Women’s Minoxidil Topical Aerosol 5% (Foam) will not affect your hair regrowth results. CAN I APPL Y WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) A ND W A SH M Y HAIR AN H O UR LAT E R? No. For Women’s Minoxidil Topical Aerosol 5% (Foam) to work best, you should allow Women’s Minoxidil Topical Aerosol 5% (Foam) to remain on the scalp for about 4 hours before washing. DIRECTIONS FOR USE: Please familiarize yourself with the instructions below in order to help make your product application a success. This product should be used ONCE DAILY , EVERY DAY. To be effective, it is important to apply the product DIRECTLY TO YOUR SCALP and NOT TO YOUR HAIR so that it can easily get to your hair follicles to help regrow your hair. There is no need to shampoo your hair before using the product. If you wish to shampoo your hair before applying Women’s Minoxidil Topical Aerosol 5% (Foam), towel dry your hair so that the skin on the scalp is dry. 1: PREP HANDS WITH COLD WATER Rinse your fingers in cold water and dry them. Note : foam will melt on contact with warm surfaces. 2: OPEN CHILD RESISTANT CAP Be sure to align arrow on the cap with arrow on white ring. Tilt cap back and pull off. 3: DISPENSE VERTICALLY ONTO A COLD SURFACE Hold the can straight upside down. If you hold the can at an angle, foam may not dispense properly. Press nozzle to dispense half a capful of foam onto a cold, surface (e.g. dish, or cold hands). 4: APPLY TO SCALP, NOT HAIR Part your hair to expose hair loss area. Massage foam into scalp , not hair. Repeat until all hair loss areas have been covered. 5: CLOSE CAP AND WASH HANDS Snap cap back into place. Be sure arrows do not line up, so cap remains child resistant. Wash hands and any surface thoroughly after use. ARE THERE ANY SPECIAL WARNINGS ABOUT THE USE OF WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? 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 more than that shown on page 4 of this booklet, 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 your doctor before use if you have heart disease. WHEN USING THI S 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 experience changes in hair color and/or texture it takes time to regrow hair. Results may occur in 3 months with once daily use. For some women you may need to use this product once daily 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 everyone. 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 (1-800-222-1222) right away. WHAT ARE THE MOST COMMON SIDE EFFECTS WITH WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? The most common side effects are itching and other skin irritation of the treated area of the scalp. Women’s Minoxidil Topical Aerosol 5% (Foam) contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If Women’s Minoxidil Topical Aerosol 5% (Foam) accidentally gets into these areas, rinse with large amounts of cool tap water. Stop using Women’s Minoxidil Topical Aerosol 5% (Foam) and contact your doctor if irritation persists. CAN WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) PRODUCE UNWANTED HAIR? Unwanted hair growth has been reported on the face and on other parts of the body with Women’s Minoxidil Topical Aerosol 5% (Foam) use. The unwanted hair growth may be caused by the transfer of Women’s Minoxidil Topical Aerosol 5% (Foam) to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of Women’s Minoxidil Topical Aerosol 5% (Foam). If you experience unwanted hair, discontinue using Women’s Minoxidil Topical Aerosol 5% (Foam) and see your doctor for recommendations about appropriate treatment. After stopping use of Women’s Minoxidil Topical Aerosol 5% (Foam), the unwanted hair, if caused by the use of Women’s Minoxidil Topical Aerosol 5% (Foam), should go away over time. You can take steps to decrease the chances for unwanted hair growth: Limit the application of Women’s Minoxidil Topical Aerosol 5% (Foam) only to the scalp; If you use your hands to apply Women’s Minoxidil Topical Aerosol 5% (Foam), wash your hands thoroughly afterwards, and Allow sufficient drying time before going to bed (usually 2 to 4 hours before going to bed after applying Women’s Minoxidil Topical Aerosol 5% (Foam). C A N I U S E WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) FOR B A LDNE SS OR HAIR L OSS I N BABIE S OR C HILDREN? No. Women’s Minoxidil Topical Aerosol 5% (Foam) must not be used to treat baldness or hair loss in babies and children. WHAT FACTORS MAY INCREASE THE RISK OF SERIOUS SIDE EFFECTS WITH WOMEN ’ S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? Women’s Minoxidil Topical Aerosol 5% (Foam) should be applied only to the scalp. The risk of side effects may be greater when Women’s Minoxidil Topical Aerosol 5% (Foam) is applied to other parts of the body. If you have any other questions, ask your health care professional or call us toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). Save this booklet for future reference. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Questions? Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Revised: 01/2024 figure figure figure figure figure figure
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 (1-800-222-1222) right 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.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 feedingMay 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 booklet keep the carton. It contains important information. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. 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.
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