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Minoxidil

Minoxidil Topical Solution for Women

Approved
Approval ID

b55198cb-40d8-432b-bdd5-2ecefa35d320

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Walgreens

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Minoxidil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-9970
Application NumberANDA074588
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minoxidil
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (4)

MINOXIDILActive
Quantity: 2 g in 100 mL
Code: 5965120SH1
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

Package label

![Minoxidil, USP 2% w/v](/dailymed/image.cfm?name=minoxidil-2-percent-topical- liquid-women-1.jpg&id=876459)

WALGREENS Hair Regrowth Treatment

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/21/2025

Use

to regrow hair on the scalp

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/21/2025

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).

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/21/2025

Active ingredient

Minoxidil, USP 2% w/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/21/2025

Purpose

Hair regrowth treatment

WARNINGS SECTION

LOINC: 34071-1Updated: 5/21/2025

Warnings

For external use only
Flammable: Keep away from fire or flame

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

Ask a doctor before use if you have

heart disease

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

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/21/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/21/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/21/2025

Questions?

Call1-877-753-3935 Monday-Friday 9AM-5PM EST

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