hair regrowth treatment for men MINOXIDIL KROGER COMPANY FDA Approved Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
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Substance Minoxidil
Route
TOPICAL
Applications
ANDA091344

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Minoxidil 5% w/w (without propellant)
Inactive Ingredients
Inactive ingredients butane butylated hydroxytoluene cetyl alcohol citric acid dehydrated alcohol isobutane lactic acid polysorbate 60 propane purified water stearyl alcohol
Strengths
5 %
Treats Conditions
Use To Regrow Hair On The Top Of The Scalp Vertex Only See Pictures On Side Of This Carton

Identifiers & Packaging

Container Type UNKNOWN
UNII
5965120SH1
Packaging

Package/Label Principal Display Panel COMPARE TO MEN’S ROGAINE ® ACTIVE INGREDIENT* Kroger ® *SEE SIDE PANEL #1 DERMATOLOGIST RECOMMENDED ACTIVE INGREDIENT EASY-TO-USE FOAM Minoxidil Topical Aerosol, 5% (Foam) Hair Regrowth Treatment FOR MEN CLINICALLY PROVEN TO HELP REGOW HAIR REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH UNSCENTED NOT FOR USE BY WOMEN ONE MONTH SUPPLY One 60 g (2.11 oz) Can 294-45-hair-regrowth-treatment

Package Descriptions
  • Package/Label Principal Display Panel COMPARE TO MEN’S ROGAINE ® ACTIVE INGREDIENT* Kroger ® *SEE SIDE PANEL #1 DERMATOLOGIST RECOMMENDED ACTIVE INGREDIENT EASY-TO-USE FOAM Minoxidil Topical Aerosol, 5% (Foam) Hair Regrowth Treatment FOR MEN CLINICALLY PROVEN TO HELP REGOW HAIR REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH UNSCENTED NOT FOR USE BY WOMEN ONE MONTH SUPPLY One 60 g (2.11 oz) Can 294-45-hair-regrowth-treatment

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings For external use only. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. 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. Minoxidil Topical Aerosol, 5% (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 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 • 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. Stop use and ask a doctor if • 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 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 right away. (1-800-222-1222)
Purpose

Purpose Hair regrowth treatment for men

Do Not Use

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. Minoxidil Topical Aerosol, 5% (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

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.

Stop Use & Ask a Doctor

Stop use and ask a doctor if • 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

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Storage & Handling

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 package and enclosed leaflet • keep the package. It contains important information. • store at controlled room temperature 20-25°C (68-77°F) • contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Questions

Questions or comments? 1-800-632-6900


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