AZELOFEIN HAIR GROWTH SOLUTION 2% MINOXIDIL TOPICAL SOLUTION
- Manufacturer
- TRILOGIC, LTD
- Effective date
- 2023-01-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:01
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Minoxidil 2% w/v
USE
Use to regrow hair on the scalp
OTC - PURPOSE SECTION
Hair regrowth treatment
WARNINGS SECTION
For external use only.
Flamable: Keep away from fire of flame.
OTC - DO NOT USE SECTION
Do not use if:
- Your degree of hair loss is different than shown on the side of this carton, because this product may not work for you
- You have no family history of hair loss
- Your hair loss is sudden and/or patchy
- Your hair loss is associated with childbirth
- You do not know the reason for your hair loss
- You are under 18 years of age. Do not use on babies or 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
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 expereinced 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 everyone.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- Chest pain, rapid heart beat, faintness, or dissiness occurs
- Sudden, unexplained weight gain occurs
- Your hands of feet swell
- Scalp irritation or redness occurs
- You get unwanted facial hair growth
- 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.
INSTRUCTIONS FOR USE 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 INFORMATION
- See hair loss pictures on the side of this carton
- Before use, read all information on carton and enclosed leaflet
- Keep the carton. It contains important information
- In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
- Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)
INDICATIONS & USAGE SECTION
Alcohol, Propylene Glycol, Purified Water
OTC - QUESTIONS SECTION
Questions or comments? +7-499-753-04-34
• Visit Website at
www.simone.su
INACTIVE INGREDIENT SECTION
Alcohol, Propylene Glycol, Purified Water
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 |
|---|---|---|---|---|---|
| 73237-001-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-742c-d83d-e063-dadaa90ab31f | AZELOFEIN HAIR GROWTH SOLUTION 2% MINOXIDIL TOPICAL SOLUTION |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73237-001-01 | AXELOFEIN | 60 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 60 | 2 | |
| 73237-001-01 | AXELOFEIN | 1 in 1 BOX | SOLUTION/ DROPS | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- AXELOFEIN
- Minoxidil 2%
- WATER
- MINOXIDIL
- ISOPROPYL ALCOHOL
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73237-001 | 73237-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | 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 |
|---|---|---|---|---|---|---|---|
| A078176-001 | THEROXIDIL | MINOXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 |
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.
| 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 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078176-001 | THEROXIDIL | 2% | SOLUTION / TOPICAL | 2007-11-09 | 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 |
|---|---|---|---|---|---|---|
| f1e96716-1fa0-51b5-e053-2a95a90a774d | 8d59713e-7925-1d00-e053-2995a90a4d67 | 2023-01-10 | Warnings | f1e96716-1fa0-51b5-e053-2a95a90a774d 8d59713e-7925-1d00-e053-2995a90a4d67 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

