Minoxidil Topical Solution For Women

Minoxidil Topical Solution For Women
SPL v4
SPL
SPL Set ID b55198cb-40d8-432b-bdd5-2ecefa35d320
Route
TOPICAL
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (2 g)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-10-14

Description

Minoxidil, USP 2% w/v

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil, USP 2% w/v

Use

to regrow hair on the scalp

Warnings

For external use 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
Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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, infected, irritated, or painful
  • you use other medicines on the scalp
Package Label
WALGREENS Hair Regrowth Treatment
Active Ingredient

Minoxidil, USP 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 of mostly white women aged 18 to 45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate 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).
Inactive Ingredients

alcohol (60% v/v), propylene glycol, purified water

Principal Display Panel

Compare to the active ingredient in Women's Rogaine®††

Minoxidal Topical Solution, USP 2%

HAIR REGROWTH TREATMENT

For Women

Topical Solution   Unscented

  • Reactivates hair follicles to stimulate regrowth
  • Clinically proven to help regrow hair
  • For best results, apply directly to scalp twice daily

mL (FL OZ) BOTTLE

††This product is not affiliated with, manufactured by, or produced by the makers or owners of Rogaine®.

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

heart disease


Structured Label Content

Use

to regrow hair on the scalp

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 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
Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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, infected, irritated, or painful
  • you use other medicines on the scalp
Package Label (Package label)
WALGREENS Hair Regrowth Treatment
Active Ingredient (Active ingredient)

Minoxidil, USP 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 of mostly white women aged 18 to 45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate 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).
Inactive Ingredients (Inactive ingredients)

alcohol (60% v/v), propylene glycol, purified water

Principal Display Panel (Principal display panel)

Compare to the active ingredient in Women's Rogaine®††

Minoxidal Topical Solution, USP 2%

HAIR REGROWTH TREATMENT

For Women

Topical Solution   Unscented

  • Reactivates hair follicles to stimulate regrowth
  • Clinically proven to help regrow hair
  • For best results, apply directly to scalp twice daily

mL (FL OZ) BOTTLE

††This product is not affiliated with, manufactured by, or produced by the makers or owners of Rogaine®.

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

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 (1-800-222-1222) 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

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