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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MINOXIDIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71713-095-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-179e-f424-e053-dadaa90a57ce | 5edbb188-5df6-8b87-e053-2991aa0a34f7 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71713-095-10 | Keeps | 3 in 1 BOX | LIQUID | 3 | 2 | |
| 71713-095-10 | Keeps | 60 mL in 1 BOTTLE, PLASTIC | LIQUID | 60 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Keeps
- Minoxidil 5%
- WATER
- MINOXIDIL
- PROPYLENE GLYCOL
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71713-095 | 71713-095-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074588-001 | MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION / TOPICAL | 1996-04-05 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074588-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-05 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6195d34f-48d8-8190-e053-2a91aa0a8638 | 5edbb188-5df6-8b87-e053-2991aa0a34f7 | 2017-12-30 | Warnings | 6195d34f-48d8-8190-e053-2a91aa0a8638 5edbb188-5df6-8b87-e053-2991aa0a34f7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
