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NDC 71713-0091-30 Minoxidil 50 mg/g Details
Minoxidil 50 mg/g
Minoxidil is a TOPICAL AEROSOL, FOAM in the HUMAN OTC DRUG category. It is labeled and distributed by Thirty MADISON, Inc.. The primary component is MINOXIDIL.
MedlinePlus Drug Summary
Minoxidil is used with other medications to treat high blood pressure. It is in a class of medications called vasodilators. It works by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 71713-0091-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Minoxidil
Minoxidil is used to stimulate hair growth and to slow balding. It is most effective for people under 40 years of age whose hair loss is recent. Minoxidil has no effect on receding hairlines. It does not cure baldness; most new hair is lost within a few months after the drug is stopped.
Related Packages: 71713-0091-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Minoxidil Topical
Product Information
| NDC | 71713-0091 |
|---|---|
| Product ID | 71713-091_19f93b56-e00a-42ee-8255-7d47f10fd273 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Minoxidil |
| Proprietary Name Suffix | 5% (For Men) |
| Non-Proprietary Name | Minoxidil |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | AEROSOL, FOAM |
| Route | TOPICAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/g |
| Substance Name | MINOXIDIL |
| Labeler Name | Thirty MADISON, Inc. |
| Pharmaceutical Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209074 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71713-0091-30 (71713009130)
| NDC Package Code | 71713-091-30 |
|---|---|
| Billing NDC | 71713009130 |
| Package | 3 CAN in 1 CARTON (71713-091-30) / 60 g in 1 CAN |
| Marketing Start Date | 2022-03-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 985ba944-147c-4207-b34b-ede702c3d704 Details
Warnings
For external use only.
For use by men only.
Do not use if
- you are a woman
- your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam 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 and children.
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp
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
- it takes time to regrow hair. Results may occur at 2 months with twice a day 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 all men.
Directions
- apply half a capful 2 times a day to the scalp in the hair loss area
- massage into scalp with fingers, then wash hands well
- see enclosed leaflet for complete directions on how to use
- 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
Other information
- hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
- 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).
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 60 g Can Carton
INGREDIENTS AND APPEARANCE
| MINOXIDIL
5% (FOR MEN)
minoxidil aerosol, foam |
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| Labeler - Thirty MADISON, Inc. (080774087) |