Growell Women's Hair Regrowth Treatment 2% Minoxidil

Growell Women's Hair Regrowth Treatment 2% Minoxidil
SPL v1
SPL
SPL Set ID 8b81a5e5-315e-4b7d-8ffd-623382294d8a
Route
TOPICAL
Published
Effective Date 2024-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (20 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-03-04

Description

Minoxidil 2% w/v

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 2% w/v

Use

to regrow hair on the top of the scalp

Section 53414-9

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

Warnings:

For external use only. 

Flammable:Keep away from fire or flame

Directions
  • apply one mL with dropper 2 times a daydirectly on to 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 wil begin again
Drug Facts

Do Not Use If:
  • your degree of hair loss is different that than  shown on the side of this carton because this product may not work on you
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • your hair loss is associated with childbirth
  • 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
Active Ingredient

Minoxidil 2% w/v

Other Information
  • See hair loss pictures on side of this carton
  • before use, reatd all information on carton and enclosed leaflet
  • 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 solution for men
  • in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: (19% of women reporting moderate hair regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25°C (68° to 77°F).
Package Labeling:

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

Call toll-free 1-(866)-982-7472

Visit our website at www.GroWellHair.com

When Using This Product
  • do not apply on the 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. 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
  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • scalp irritation or redness occurs
  • sudden, unexplained weight gain occurs
  • unwanted facial hair growth occurs
  • your hands or feet swell
  • you do not see hair regrowth in 4 months
Keep Out of Reach of Children.

If swallowed, get medical help, or contact a Poison Contrl Center right away.

Ask A Doctor Before Use If You Have

heart disease


Structured Label Content

Use

to regrow hair on the top of the scalp

Section 53414-9 (53414-9)

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

Purpose

Hair regrowth treatment

Warnings:

For external use only. 

Flammable:Keep away from fire or flame

Directions
  • apply one mL with dropper 2 times a daydirectly on to 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 wil begin again
Drug Facts

Do Not Use If: (Do not use if:)
  • your degree of hair loss is different that than  shown on the side of this carton because this product may not work on you
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • your hair loss is associated with childbirth
  • 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
Active Ingredient (Active ingredient)

Minoxidil 2% w/v

Other Information (Other information)
  • See hair loss pictures on side of this carton
  • before use, reatd all information on carton and enclosed leaflet
  • 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 solution for men
  • in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: (19% of women reporting moderate hair regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25°C (68° to 77°F).
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments? (Questions or comments?)

Call toll-free 1-(866)-982-7472

Visit our website at www.GroWellHair.com

When Using This Product (When using this product)
  • do not apply on the 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. 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 (Stop use and ask a doctor if)
  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • scalp irritation or redness occurs
  • sudden, unexplained weight gain occurs
  • unwanted facial hair growth occurs
  • your hands or feet swell
  • 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 Contrl Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)