colorsmith hair regrowth treatment men's 5% minoxidil topical solution, extra strength

colorsmith hair regrowth treatment men's 5% minoxidil topical solution, extra strength
SPL v1
SPL
SPL Set ID 69b01eab-df9f-4ae8-87e4-add18883874b
Route
topical
Published
Effective Date 2024-10-31
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 2024-10-16

Purpose

Hair regrowth treatment for men

Description

Minoxidil 5% w/v


Medication Information

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame.

Purpose

Hair regrowth treatment for men

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

Alcohol, Propylene Glycol, Purified Water

Description

Minoxidil 5% w/v

Use

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

Section 53414-9

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

Drug Facts

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, inflamed, infected, irritated or painful
  • you use other medicines on the scalp
Active Ingredient

Minoxidil 5% w/v

Package Labeling:

Questions Or Comments?

Call your health professional or Colorsmith at toll free (866) 550-2424.

Visit website at Colorsmith.co

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 least 2 months with twice a day usage. For some men, you may need to use this product for at least 4 monhs 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
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have

heart disease.


Structured Label Content

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame.

Purpose

Hair regrowth treatment for men

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
Other Information (Other information)
  • see hair loss pictures on side of this carton.
  • before use, read 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 men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 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

Use

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

Section 53414-9 (53414-9)

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

Drug Facts

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, inflamed, infected, irritated or painful
  • you use other medicines on the scalp
Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Package Labeling:

Questions Or Comments? (Questions or comments?)

Call your health professional or Colorsmith at toll free (866) 550-2424.

Visit website at Colorsmith.co

When Using This Product (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 least 2 months with twice a day usage. For some men, you may need to use this product for at least 4 monhs 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
  • 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.

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

heart disease.


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