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NDC 61269-0094-75 Minoxidil 5 g/100mL Details
Minoxidil 5 g/100mL
Minoxidil is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by H2-Pharma, LLC. 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: 61269-0094-75Last 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: 61269-0094-75Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Minoxidil Topical
Product Information
| NDC | 61269-0094 |
|---|---|
| Product ID | 61269-094_4162d466-6dd6-406e-ba78-253eb04f394b |
| Associated GPIs | 90738050102025 |
| GCN Sequence Number | 029098 |
| GCN Sequence Number Description | minoxidil SOLUTION 5 % TOPICAL |
| HIC3 | Q5C |
| HIC3 Description | TOPICALS, HYPERTRICHOTIC AGENTS |
| GCN | 01232 |
| HICL Sequence Number | 000093 |
| HICL Sequence Number Description | MINOXIDIL |
| Brand/Generic | Generic |
| Proprietary Name | Minoxidil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Minoxidil |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | g/100mL |
| Substance Name | MINOXIDIL |
| Labeler Name | H2-Pharma, LLC |
| Pharmaceutical Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075518 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 61269-0094-75 (61269009475)
| NDC Package Code | 61269-094-75 |
|---|---|
| Billing NDC | 61269009475 |
| Package | 2 BOTTLE, DROPPER in 1 CARTON (61269-094-75) / 60 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2022-04-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f33502d3-e330-48d1-a38e-b98cf0b14b61 Details
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
Do not use if
- you are a woman
- 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 5% 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
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.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
- in clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
- store at controlled room temperature 20° to 25°C (68° to 77°F)
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
NDC 61269-094-75
*Compare to the active ingredient in
Men's Rogaine®
FOR MEN
EXTRA STRENGTH
Minoxidil
Topical Solution,
USP 5%
Hair regrowth treatment
Reactivates hair follicles to stimulate regrowth
Clinically proven to help regrow hair
Unscented
NOT FOR USE BY WOMEN
FOR BEST RESULTS
Apply directly to scalp twice daily
TWO MONTH SUPPLY
Two 60 mL (2 fl oz) bottles
H2 pharma
INGREDIENTS AND APPEARANCE
| MINOXIDIL
minoxidil solution |
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| Labeler - H2-Pharma, LLC (028473634) |