Foligain Professional Series Extra Strength for Women Minoxidil Topical Solution USP 2% Hair Regrowth Treatment

Manufacturer
WR Group, Inc. | Pure Source, LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:13

Label at a glance#

ProductFoligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment
Active ingredientMINOXIDIL
Label structure8 sections

Dosage and administration

• Apply 1 mL with dropper two (2) times a day directly onto the scalp in the hair loss area. • Using more product, or using product more often will not improve results. • Continued use is necessary to increase and maintain your hair regrowth, or hair loss will begin again.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 2% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for women

Use

INDICATIONS & USAGE SECTION

to regrow hair on the scalp. (see picture on side of carton)

Warnings

WARNINGS SECTION

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

Do not use if you:

OTC - DO NOT USE SECTION

• have hair loss associated with childbirth.
• have hair loss other than that shown on the side of this carton, because this product may not work for you.
• have no family history of hair loss.
• have sudden and/or patchy hair loss.
• do not know the reason for your hair loss.
• are under 18 years of age.
• have a red, inflamed, infected, irritated or painful-feeling scalp.
• use other medicines on the scalp.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

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. Results may occur at 2 months with twice a day usage. For some women, you may need to use this product 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 you experience:

OTC - STOP USE SECTION

• chest pain, rapid heartbeat, faintness, or dizziness.
• sudden, unexplained weight gain.
• swelling of the hands or feet.
• scalp irritation or redness.
• unwanted facial hair growth.
• no 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply 1 mL with dropper two (2) times a day directly onto the scalp in the hair loss area.
• Using more product, or using product more often will not improve results.
• Continued use is necessary to increase and maintain your hair regrowth, or hair loss will begin again.

Other information

SPL UNCLASSIFIED 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.
• Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 2% minoxidil topical solution for women.
• In clinical studies of mostly white women aged 18-49 years with moderate degrees of hair loss, 2% minoxidil topical solution for women provided more hair regrowth than 2% minoxidil topical solution.
• Store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water.

Questions or comments?

OTC - QUESTIONS SECTION

• call us at +1 (844) 473-7279
• visit www.foligain.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner PackagePackage InsertPackage InsertPackage Insert2Package Insert2

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850080512050GTIN-13: 0850080512050
EAN-13: 0850080512050
GTIN-12: 850080512050
UPC-A: 850080512050
GTIN storage (14 digits): 00850080512050
Outer Package.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69607-9530-0Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment3 in 1 BOXSOLUTION31
69607-9530-0Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment60 mL in 1 BOTTLE, DROPPERSOLUTION601

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
69607-953069607-9530-0

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

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09c2088c7a36db…
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…

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
Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth TreatmentMINOXIDILWR Group, Inc.a765cc59-ab59-4e49-ba28-926a2e0a78b12026-05-13WarningsExact identifier
ndc (package): 69607-9530-0
ndc (product): 69607-9530
ndc11 (package): 69607953000
spl id: 51b0803c-0bbd-c834-e063-6294a90aab95
spl set id: a765cc59-ab59-4e49-ba28-926a2e0a78b1

Reported adverse events (FAERS/openFDA)#

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