Minoxidil Extra Strength for Men MINOXIDIL ROMAN HEALTH VENTURES INC. FDA Approved Bottle Carton Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton) 3 Bottle Carton Use to regrow hair on the scalp
FunFoxMeds bottle
Substance Minoxidil
Route
TOPICAL
Applications
ANDA076239

Drug Facts

Composition & Profile

Active Ingredients
1 Bottle Carton Active ingredient Minoxidil USP 5% w/v 3 Bottle Carton Active ingredient Minoxidil 5% w/v
Inactive Ingredients
Inactive ingredients Alcohol propylene glycol purified water
Strengths
5 %
Quantities
60 ml
Treats Conditions
1 Bottle Carton Use To Regrow Hair On The Top Of The Scalp Vertex Only See Pictures On Side Of Carton 3 Bottle Carton Use To Regrow Hair On The Scalp

Identifiers & Packaging

Container Type BOTTLE
UNII
5965120SH1
Packaging

Single Bottle Package NDC 72484-095-03 Men's Extra Strength HAIR REGROWTH TREATMENT roman MINOXIDIL TOPICAL SOLUTION USP 5% Reactivates hair follicles to stimulate regrowth Clinically proven to help regrow hair NOT FOR USE BY WOMEN Unscented Topical Solution One month supply One 60 mL (2 fl oz) Bottle 72484-095-03 Minoxidil Retail; Three bottle package NDC 72484-095-06 Men's Extra Strength HAIR REGROWTH TREATMENT roman MINOXIDIL TOPICAL SOLUTION USP 5% Reactivates hair follicles to stimulate regrowth Clinically proven to help regrow hair NOT FOR USE BY WOMEN Unscented Topical Solution Three month supply Three 60 mL (2 fl oz) bottles 72484-095-06

Package Descriptions
  • Single Bottle Package NDC 72484-095-03 Men's Extra Strength HAIR REGROWTH TREATMENT roman MINOXIDIL TOPICAL SOLUTION USP 5% Reactivates hair follicles to stimulate regrowth Clinically proven to help regrow hair NOT FOR USE BY WOMEN Unscented Topical Solution One month supply One 60 mL (2 fl oz) Bottle 72484-095-03 Minoxidil Retail
  • Three bottle package NDC 72484-095-06 Men's Extra Strength HAIR REGROWTH TREATMENT roman MINOXIDIL TOPICAL SOLUTION USP 5% Reactivates hair follicles to stimulate regrowth Clinically proven to help regrow hair NOT FOR USE BY WOMEN Unscented Topical Solution Three month supply Three 60 mL (2 fl oz) bottles 72484-095-06

Overview

Bottle Carton Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton) 3 Bottle Carton Use to regrow hair on the scalp

Indications & Usage

Bottle Carton Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton) 3 Bottle Carton Use to regrow hair on the scalp

Dosage & Administration

Directions apply one ml with dropper 2 times a day directly onto the scalp in the hair loss area 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. 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 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.
Purpose

1 Bottle Carton Purpose Hair regrowth treatment for men 3 Bottle Carton Purpose Hair regrowth treatment

Do Not Use

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

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.

Questions

Questions? 1-424-347-6299 between 9:30 am and 9:00 pm EST, Monday–Friday.


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