Minoxidil Topical Solution

Manufacturer
H2-Pharma, LLC
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:43:46

Label at a glance#

ProductMinoxidil
Active ingredientMINOXIDIL
Label structure11 sections

Dosage and administration

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

Storage and handling

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 men aged 18 to 49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil, USP 2% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Flammable: Keep away from fire or flame

Do not use if

OTC - DO NOT USE SECTION

  • 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
  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have heart disease.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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 men aged 18 to 49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution 2% for men for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
  • store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61269-066-75

*Compare to the active ingredient in
Men's Rogaine®

FOR MEN
Minoxidil
Topical Solution,
USP 2%
Hair regrowth treatment

Reactivates hair follicles to stimulate regrowth
Clinically proven to help regrow hair
Unscented

FOR BEST RESULTS
Apply directly to scalp twice daily

TWO MONTH SUPPLY
Two 60 mL (2 fl oz) bottles

H2 pharma

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-066MINOXIDIL SOLUTION [H2-PHARMA, LLC]2Unmatched20250101_288677b3-8ede-403a-8fc7-d9d788d985af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-066-73ML - Milliliter61269-0669cdab7f4-2f11-4a9a-862e-df0cd7ac24fe12024-01-04
61269-066-75ML - Milliliter61269-0669115e005-59e3-4eb7-908f-da98467e190a12024-01-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61269-06661269-066-73, 61269-066-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7b74333f-0941-4353-b4e1-3113d9adb197288677b3-8ede-403a-8fc7-d9d788d985af2024-12-30WarningsExact identifier
spl id: 7b74333f-0941-4353-b4e1-3113d9adb197
spl set id: 288677b3-8ede-403a-8fc7-d9d788d985af

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.