Keeps

Manufacturer
Thirty Madison Inc
Effective date
2017-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:53

Label at a glance#

ProductKeeps
Active ingredientMINOXIDIL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5.0% w/v

OTC - PURPOSE SECTION

Hair regrowth treatment for men

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only. For use by men only.
Flammable: Keep away from fire or flame
Do not use if:
• you are a woman
• your amount of hair loss is different than that shown on the side of this
carton or your hair loss is on the front of the scalp, 5% minoxidil topical
solution 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, 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. 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 different for each person.
• this product will not work for all men
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.

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.

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 SAFETY 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.
• hair regrowth has not been shown to last longer than 48 weeks
in large clinical trials with continuous treatment with 5% minoxidil
topical solution for men
• in clinical studies of mostly white men aged 18-49 years with
moderate degrees of hair loss, 5% minoxidil topical solution for men
provided more hair regrowth than 2% minoxidil topical solution
• store at controlled room temperature 20º to 25ºC (68º to 77ºF).

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

OTC - QUESTIONS SECTION

Questions or comments?
1-833-745-3377

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box artbox art

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN2
311724minoxidil 50 MG/ML Topical SolutionSCD2
311724minoxidil 3 GM per 60 ML Topical SolutionSY2
311724minoxidil 5 % Topical SolutionSY2
311724minoxidil 5 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
71713-095-102020-01-31C16284748780-19d75b9d0-179e-f424-e053-dadaa90a57ce5edbb188-5df6-8b87-e053-2991aa0a34f7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71713-095-10Keeps3 in 1 BOXLIQUID32
71713-095-10Keeps60 mL in 1 BOTTLE, PLASTICLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71713-095KEEPS (MINOXIDIL 5%) LIQUID [THIRTY MADISON INC]2Legacy NDC, 2 package rows20171231_5edbb188-5df6-8b87-e053-2991aa0a34f7.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
71713-09571713-095-10

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
A074588-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1996-04-05

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 22:38:342026-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0584e616aacf4f…
2026-08-18 06:07:402026-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05f41ea6bd6efb…

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
6195d34f-48d8-8190-e053-2a91aa0a86385edbb188-5df6-8b87-e053-2991aa0a34f72017-12-30WarningsExact identifier
spl id: 6195d34f-48d8-8190-e053-2a91aa0a8638
spl set id: 5edbb188-5df6-8b87-e053-2991aa0a34f7

Reported adverse events (FAERS/openFDA)#

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