Men's Extra Strength Hair Regrow

Men's Extra Strength Hair Regrow
SPL v2
SPL
SPL Set ID 7e5d9cc3-1fae-4e68-8184-37f749f0a07f
Route
TOPICAL
Published
Effective Date 2018-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2004-08-24

Description

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

Description

Minoxidil 5% w/v

Use

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

​Ask a doctor before use if you have heart disease

Section 53414-9

​May be harmful if used when pregnant or breast feeding. 

Warnings

For external use only.  For use by men only.

Flammable: Keep away from fire or flame

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.
Drug Facts

Questions?
  • 1-866-270-HAIR (4247)

9 am to 2 pm weekdays EST

  • Visit www.MyHairRegrow.com
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.  5% minoxidil topical solution 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, inflammed, infected, irritated, or painful
  • you use other medicines on the scalp
Active Ingredient

Minoxidil 5% w/v

Other Information
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet.
  • 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 5% minoxidil topical solutions for men.
  • In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.
  • store at controlled room temperature 20° to 25° C (68° to 77° F)
Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

When Using This Product
  • do not apply on other part of the body
  • avoid contact with the eyes.  In case of accidental contact, rinse eyes with large amounts of cool tap water.
  • some individuals (people) have experienced changes in hair color and/or texture
  • it takes time to regrow hair.  Results may occur at 2 months with 2 times daily usage of this product.  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
  • you get unwanted facial hair growth
  • you do not see hair regrowth in 4 months
Men's Extra Strength Hair Regrow

Help regrow your hair with confidence

5% Minoxidil Topical Solution

Hair Regrowth Treatment

Unscented

Extra Strength Formula

Reactivates hair follicles to stimulate regrowth

Minoxidil is clinically proven to help regrow hair

Compare to Men's Rogaine​® Active Ingredient*

Not for use by women

30 day supply / 1-60 mL (2 fl oz) bottle


Structured Label Content

Use

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

​Ask a doctor before use if you have heart disease

Section 53414-9 (53414-9)

​May be harmful if used when pregnant or breast feeding. 

Purpose

Hair regrowth treatment for men

Warnings

For external use only.  For use by men only.

Flammable: Keep away from fire or flame

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.
Drug Facts

Questions?
  • 1-866-270-HAIR (4247)

9 am to 2 pm weekdays EST

  • Visit www.MyHairRegrow.com
Do Not Use If (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.  5% minoxidil topical solution 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, inflammed, infected, irritated, or painful
  • you use other medicines on the scalp
Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Other Information (Other information)
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet.
  • 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 5% minoxidil topical solutions for men.
  • In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.
  • store at controlled room temperature 20° to 25° C (68° to 77° F)
Inactive Ingredients (Inactive ingredients)

Alcohol, Propylene Glycol, Purified Water

When Using This Product (When using this product)
  • do not apply on other part of the body
  • avoid contact with the eyes.  In case of accidental contact, rinse eyes with large amounts of cool tap water.
  • some individuals (people) have experienced changes in hair color and/or texture
  • it takes time to regrow hair.  Results may occur at 2 months with 2 times daily usage of this product.  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 (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
  • you get unwanted facial hair growth
  • you do not see hair regrowth in 4 months
Men's Extra Strength Hair Regrow (Men's Extra Strength HAIR Regrow)

Help regrow your hair with confidence

5% Minoxidil Topical Solution

Hair Regrowth Treatment

Unscented

Extra Strength Formula

Reactivates hair follicles to stimulate regrowth

Minoxidil is clinically proven to help regrow hair

Compare to Men's Rogaine​® Active Ingredient*

Not for use by women

30 day supply / 1-60 mL (2 fl oz) bottle


Advanced Ingredient Data


Raw Label Data

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