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

Loesch Hair Regrowth Formula by

Drug Labeling and Warnings

Loesch Hair Regrowth Formula by is a Otc medication manufactured, distributed, or labeled by Loesch Laboratory Consultant, INC., Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075598	07/30/2014

Labeler - Loesch Laboratory Consultant, INC. (026619510)

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