• Apply 1 mL with sprayer (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.
Minoxidil, 5% w/v (in each 1mL dose)
Hair Regrowth Topical Treatment
• For external use only.
• For use by men only.
• Flammable: Keep away from fire or flame.
• 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. Minoxidil Topical Solution, 5% 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 medications on the scalp.
YOU HAVE HEART DISEASE.
• 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.
If swallowed, get medical help or contact a Poison Control Center right away.
• Side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Salonceuticals, Inc. at 1-877-706-8688
• Chest pain, rapid heartbeat, faintness, or dizziness occurs.
• Sudden, unexplained weight gain occurs.
• Your hands or feet swell.
• Scalp irritation occurs, and continues or worsens.
• Unwanted facial hair growth occurs.
• Apply 1 mL with sprayer (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.
• See hair loss pictures on side of this carton.
• Before use, read all information on carton and enclosed booklet.
• 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 Minoxidil Topical Solution 5%.
• In clinical studies with mostly white men age 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% provided more hair regrowth than Minoxidil Topical Solution, 2%.
• Store at USP controlled room temperature 20° to 25°C (68° to 77°F).
• Alcohol 30% v/v, propylene glycol 50% v/v, purified water
• Call your health professional or Salonceuticals, Inc. at 1-877-706-8688, Monday—Friday: 9:00am—5:00pm (EST)
| Class | Version | Type | Effective |
|---|---|---|---|
| MINOXIDIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71290-813-02 | Regenpure Precision | 1 in 1 BOX | LIQUID | 1 | 1 | |
| 71290-813-02 | Regenpure Precision | 60 mL in 1 BOTTLE | LIQUID | 60 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71290-813 | 71290-813-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076239-001 | THEROXIDIL | MINOXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 |
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 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Regenpure Precision | MINOXIDIL | Salonceuticals, Inc. | 4a113921-b2a9-42cc-e054-00144ff8d46c | 2017-03-06 | Warnings | 71290-813-02 71290-813 71290081302 4a116d5a-332b-68b6-e054-00144ff88e88 4a113921-b2a9-42cc-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.