EXT Hair Regrowth Treatment for Men 2%

Manufacturer
TTEM, LLC
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:19

Label at a glance#

ProductEXT Hair Regrowth Treatment for Men 2%
Active ingredientMINOXIDIL
Label structure14 sections

Dosage and administration

Directions ■ apply one mL with dropper 2 times a day directly onto the scalp in the area of hair loss ■ 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#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 2% w/v

USE

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION

Hair regrowth treatment

WARNINGS SECTION

For external use only

Flammable: Keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use if

■ you are a woman ■ your amount of hair loss is dierent than that

shown on the side of this carton, or your hair loss is on the front of the

scalp. EXT Hair Regrowth Treatment is not intended for frontal baldness

or receding hairline. ■ 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

OTC - WHEN USING SECTION

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. Results may occur at 2 months with

twice a day usage. For some men, you may need to use this product

for at least 4 months before you see results.

■ the amount of hair regrowth is dierent for each person. This

product will not work for everyone.

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ side eects occur. You may report side eects to FDA at

1.800.FDA.1088

■ 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 right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

■ apply one mL with dropper 2 times a day directly onto the scalp in

the area of hair loss

■ 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 SAFETY INFORMATION

Other information

■ see hair loss pictures on side of this carton

■ before use, read all information on carton and enclosed leaflet

■ keep this carton. It contains important information.

■in clinical studies of mostly white men aged 18-49 years with moderate

degrees of hair loss, the following response to minoxidil topical solution

2% was reported: 26% of men reported moderate to dense hair regrowth

after using minoxidil topical solution 2% 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 between 68° - 77°F

(20°-25°C). Keep tightly closed.

INACTIVE INGREDIENT SECTION

Inactive ingredients

alcohol, propylene glycol, purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311723minoxidil 2 % Topical SolutionPSN2
311723minoxidil 20 MG/ML Topical SolutionSCD2
311723minoxidil 2 % Topical SolutionSY2
311723minoxidil 2 GM per 100 ML Topical SolutionSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70150-002-012025-01-30C16284748780-12cef2736-7301-d83d-e063-dadaa90ab31fEXT Hair Regrowth Treatment for Men 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70150-002-01EXT Hair Regrowth Treatment for Men 2%1 in 1 BOXSOLUTION12
70150-002-01EXT Hair Regrowth Treatment for Men 2%60 mL in 1 BOTTLESOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70150-002EXT HAIR REGROWTH TREATMENT FOR MEN 2% (MINOXIDIL 2%) SOLUTION [TTEM, LLC]2Legacy NDC, 2 package rows20230119_923f822b-90b9-d09f-e053-2a95a90a450c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70150-00270150-002-01

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 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
f28bdfa1-c6c2-452a-e053-2995a90adcdd923f822b-90b9-d09f-e053-2a95a90a450c2023-01-18WarningsExact identifier
spl id: f28bdfa1-c6c2-452a-e053-2995a90adcdd
spl set id: 923f822b-90b9-d09f-e053-2a95a90a450c

Reported adverse events (FAERS/openFDA)#

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