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NDC 25280-0007-42 Loesch Hair Regrowth Formula 2 g/100mL Details
Loesch Hair Regrowth Formula 2 g/100mL
Loesch Hair Regrowth Formula is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Loesch Laboratory Consultant, 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: 25280-0007-42Last Updated: 11/30/2022
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: 25280-0007-42Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Minoxidil Topical
Product Information
NDC | 25280-0007 |
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Product ID | 25280-007_97f30e90-b82b-9e29-e053-2a95a90a7f62 |
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 | Loesch Hair Regrowth Formula |
Proprietary Name Suffix | Unscented Topical Solution Regular-Strength for Men and Women |
Non-Proprietary Name | minoxidil |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | TOPICAL |
Active Ingredient Strength | 2 |
Active Ingredient Units | g/100mL |
Substance Name | MINOXIDIL |
Labeler Name | Loesch Laboratory Consultant, INC. |
Pharmaceutical Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA075357 |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 25280-0007-42 (25280000742)
NDC Package Code | 25280-007-42 |
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Billing NDC | 25280000742 |
Package | 1 BOTTLE, WITH APPLICATOR in 1 PACKAGE (25280-007-42) / 60 mL in 1 BOTTLE, WITH APPLICATOR |
Marketing Start Date | 2014-08-11 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b9ff7a22-74be-4968-a260-576c7348dfb1 Details
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.
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
Keep out of reach of children
Directions
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.
INGREDIENTS AND APPEARANCE
LOESCH HAIR REGROWTH FORMULA
UNSCENTED TOPICAL SOLUTION REGULAR-STRENGTH FOR MEN AND WOMEN
minoxidil solution |
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Labeler - Loesch Laboratory Consultant, INC. (026619510) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Bio-Medical & Pharmaceutical Manufacturing Corporation | 072186356 | relabel(25280-007) |