Indications and uses
To regrow hair on the scalp (vertex only, see picture on side of carton)
Olivita Extra Strength 5% Minoxidil Topical Solution USP
- Manufacturer
- Olivita Beauty Inc | Pure Source, LLC
- Effective date
- 2026-08-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-08-20 01:02:00
Label at a glance#
ProductOlivita Extra Strength Minoxidil
Active ingredientMINOXIDIL
Label structure8 sections
Dosage and administration
• prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray Do not inhale mist • apply one ml with spray (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
Contacts and useful links#
Websitewww.olivitabeauty.com
www.olivitabeauty.com
www.olivitabeauty.comLabel contents#
Full prescribing information#
Active Ingredient**
Minoxidil 5% w/v
Purpose*
Hair regrowth treatment for men
Uses
To regrow hair on the scalp (vertex only, see picture on side of carton)
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
Do not use
• 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
When Using
• 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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children
Directions
• prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray Do not inhale mist • apply one ml with spray (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
Other 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 18–45 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 20° to 25°C (68° to 77°F).
Inactive ingredients
Alcohol, Propylene Glycol, Purified Water
Questions or Comments?
+1 (646) 736-4799
Visit Website at: www.olivitabeauty.com
Package Labeling:
Products#
Every source-derived product name is available through these pages.
- Olivita Extra Strength Minoxidil
- MINOXIDIL
- ALCOHOL
- PROPYLENE GLYCOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87695-008 | 87695-008-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINOXIDIL | 5965120SH1 | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|---|
| A076239-001 | THEROXIDIL | MINOXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 |
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 | 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 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 |
|---|---|---|---|---|---|---|
| Olivita Extra Strength Minoxidil | MINOXIDIL | Olivita Beauty Inc | b2da549b-eb79-46ed-aaec-87326c4a1fbe | 2026-08-17 | Warnings | 87695-008-00 87695-008 87695000800 593f9d01-5c19-7e54-e063-6294a90a9664 b2da549b-eb79-46ed-aaec-87326c4a1fbe |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.