Search by Drug Name or NDC

NDC 25280-0006-42 Loesch Hair Regrowth Formula 3 g/60mL Details

Loesch Hair Regrowth Formula 3 g/60mL

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: 25280-0006-42
Last 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: 25280-0006-42
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Minoxidil Topical

Product Information

NDC	25280-0006
Product ID	25280-006_9848a2a3-4521-6e62-e053-2995a90a1a0a
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 Extra-Strength for Men
Non-Proprietary Name	minoxidil
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	g/60mL
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	ANDA075598
Listing Certified Through	2024-12-31

Package

Package Images

NDC 25280-0006-42 (25280000642)

Pricing Information	N/A
NDC Package Code	25280-006-42
Billing NDC	25280000642
Package	1 BOTTLE, WITH APPLICATOR in 1 PACKAGE (25280-006-42) / 60 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2014-07-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d158d3af-6850-48c0-8355-9df0637684cc Details

Drug Facts

Active Ingredients

Minoxidil 5% w/v

Purpose

Hair Regrowth Treatment For Men

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).

Warnings

For external use 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 or children.

Your scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

ASK DOCTOR

Ask a doctor before use if you have heart disease.

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

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 4 months.

Pregnancy or breast feeding

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 immediately. (1-800-222-1222)

Directions

Apply one mL 2 times daily directly onto the scalp in the hair loss area.

Using more or more often will not improve results.

Continued use is necessary or hair loss will resume.

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 5%.

In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%.

Inactive Ingredients

Alcohol, Propylene Glycol, Purified water

Questions or Comments?

1-800-237-7157

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOESCH HAIR REGROWTH FORMULA UNSCENTED TOPICAL SOLUTION EXTRA-STRENGTH FOR MEN

minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:25280-006(NDC:63981-798)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	3 g in 60 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:25280-006-42	1 in 1 PACKAGE	07/30/2014
1		60 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075598	07/30/2014

Labeler - Loesch Laboratory Consultant, INC. (026619510)

Name	Address	ID/FEI	Business Operations
Establishment
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	relabel(25280-006)

Revised: 11/2019

Document Id: 9848a2a3-4521-6e62-e053-2995a90a1a0a

Set id: d158d3af-6850-48c0-8355-9df0637684cc

Version: 3

Effective Time: 20191126