Esalon Hair Regrowth Treatment Women's 2% Minoxidil Topical Solution

Esalon Hair Regrowth Treatment Women's 2% Minoxidil Topical Solution
SPL v1
SPL
SPL Set ID c3951cc3-83c1-4d9d-8fbe-db6f1fb3986c
Route
TOPICAL
Published
Effective Date 2024-11-01
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 2024-10-16

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 scalp.

Section 53414-9

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

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Directions
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply 1 mL with sprayer (6 sprays)  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 keepyour hair regrowth, or hair loss will begin again
Drug Facts

Do Not Use If:
  • your degree of hair loss is different than that shown on the side of this carton, because this product may not work for 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, 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, read all information on carton and enclosed leaflet.
  • keep the carton. It contains important information.
  • in clinical studies with mostly white women age 18-45 years with mild to moderate degrees of hair loss, the follwing response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using women's minoxidil topical solution 2% for 8 months: (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting hair regrowth after using the 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 your health professional or eSalon at (866) 550-2424

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. You may need to use this product 2 times  a day 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
  • 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

Use

to regrow hair on the scalp.

Section 53414-9 (53414-9)

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

Purpose

Hair regrowth treatment

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Directions
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply 1 mL with sprayer (6 sprays)  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 keepyour hair regrowth, or hair loss will begin again
Drug Facts

Do Not Use If: (Do not use if:)
  • your degree of hair loss is different than that shown on the side of this carton, because this product may not work for 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, 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, read all information on carton and enclosed leaflet.
  • keep the carton. It contains important information.
  • in clinical studies with mostly white women age 18-45 years with mild to moderate degrees of hair loss, the follwing response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using women's minoxidil topical solution 2% for 8 months: (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting hair regrowth after using the 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 your health professional or eSalon at (866) 550-2424

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. You may need to use this product 2 times  a day 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
  • 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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