FDA.reportPublic FDA data

BOSLEY Minoxidil Topical Solution 2 for Women

Manufacturer
Scientific Hair Research, LLC
Effective date
2024-02-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:59

Label at a glance#

ProductBOSLEY Minoxidil Topical Solution 2 for Women
Active ingredientMINOXIDIL
Label structure8 sections

Dosage and administration

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 one ml. (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 keep your hair regrowth, or hair loss will begin again

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 2.0%w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for women

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Flammable:keep away from fire or flame

Do not use if:

OTC - DO NOT USE SECTION

  • your amount of hair loss is different than that shown on the side of this box 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 medications on the scalp

Ask a doctor before use if you have 

OTC - ASK DOCTOR SECTION

heart disease

When using this product

OTC - WHEN USING SECTION

  • do not apply on other parts of the body 
  • avoid contact with 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 all women.

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 

May be harmful if used

when pregnant or breastfeeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 one ml. (6 sprays) 2 times a daydirectly 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

SPL UNCLASSIFIED SECTION

  • see hair loss pictures on side of this box
  • before use, read all information on carton and enclosed insert
  • keep carton, it contains important information 
  • in clinical studies with mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using woman'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)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

Call us at 1-800-267-5391 or visit website at www.bosleymd.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.jpgLabel.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311723minoxidil 2 % Topical SolutionPSN1
311723minoxidil 20 MG/ML Topical SolutionSCD1
311723minoxidil 2 % Topical SolutionSY1
311723minoxidil 2 GM per 100 ML Topical SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69113-462-00BOSLEY Minoxidil Topical Solution 2 for Women1 in 1 BOXLIQUID11
69113-462-00BOSLEY Minoxidil Topical Solution 2 for Women60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69113-462BOSLEY MINOXIDIL TOPICAL SOLUTION 2 FOR WOMEN (MINOXIDIL) LIQUID [SCIENTIFIC HAIR RESEARCH, LLC]1Current NDC, 2 package rows20240226_4fe1602f-797a-4469-b82c-3ade8a9c7fec.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69113-46269113-462-00

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
MINOXIDIL5965120SH1ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078176-001THEROXIDILMINOXIDIL2%SOLUTION / TOPICAL2007-11-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09f41ea6bd6efb…

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
BOSLEY Minoxidil Topical Solution 2 for WomenMINOXIDILScientific Hair Research, LLC4fe1602f-797a-4469-b82c-3ade8a9c7fec2024-02-21WarningsExact identifier
ndc (package): 69113-462-00
ndc (product): 69113-462
ndc11 (package): 69113046200
spl id: 11e25c49-3b44-268b-e063-6294a90a3021
spl set id: 4fe1602f-797a-4469-b82c-3ade8a9c7fec

Reported adverse events (FAERS/openFDA)#

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