Minoxidil 5%
- Manufacturer
- Centro Internacional de Cosmiatría, S.A.P.I. de C.V.
- Effective date
- 2024-02-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:11:39
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
WARNINGS SECTION
Warnings
For external use only
Flammable: Keep away from fire or flame.
Do not use if
your degree of hair loss is different than that 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 it on babies and children.
your scalp is red, inflamed, infected, 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. You may need to use this product 2 times a day 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.
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.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS
Before each application, 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 1 mL with sprayer (8 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.
INACTIVE INGREDIENT SECTION
ALCOHOL 3K9958V90M 0.25 g IACT
ANHYDROUS CITRIC ACID XF417D3PSL 0.0093 g IACT
BUTYLATED HYDROXYTOLUENE 1P9D0Z171K 0.001 g IACT
PROPYLENE GLYCOL 6DC9Q167V3 0.637 g IACT
WATER 059QF0KO0R 0.0827 g IACT
INDICATIONS & USAGE SECTION
Purpose
Hair regrowth treatment.
Use
To regrow hair on the scalp.
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. (1-800-222-1222)
OTC - PURPOSE SECTION
Hair regrowth treatment
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Minoxidil 2%
- Minoxidil
- ALCOHOL
- ANHYDROUS CITRIC ACID
- BUTYLATED HYDROXYTOLUENE
- PROPYLENE GLYCOL
- WATER
- Minoxidil 5%
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77229-050 | 77229-050-01, 77229-050-13, 77229-050-16 |
| 77229-099 | 77229-099-01, 77229-099-13, 77229-099-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 21c859a9-1e86-48ac-e063-6394a90a5443 | 10cf794b-3c6f-4802-e063-6394a90a700f | 2024-09-10 | Warnings | 10cf794b-3c6f-4802-e063-6394a90a700f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

