5% Minoxidil Spray

Manufacturer
Consilii LLC
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:20:10

Label at a glance#

Product5% Minoxidil Spray.
Active ingredientMINOXIDIL
Label structure14 sections

Dosage and administration

Apply 5 sprays 2 times a day directly to the scalp in the hair loss area Using more than directed or more often will not improve results. Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Storage and handling

see hair loss pictures on side of this carton Before use, read all information on the carton 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 aerosol 5% for men in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical aeros...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5%

Purpose

OTC - PURPOSE SECTION

Hair Regrowth Treatment

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

WARNINGS SECTION

For external use only

For use by men only

Do not use

OTC - DO NOT USE SECTION

your amount of hair loss is different than that shown on 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

You have no family history of hair loss,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 it on babies and children

scalp is red,inflamed,infected,irritated,or painful

you use other medicines on th scalp

When Using

OTC - WHEN USING SECTION

Do not apply on other parts of the body

avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount 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

OTC - STOP USE SECTION

chest pain, rapid heart beat, 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

Ask Doctor

OTC - ASK DOCTOR SECTION

When Pregnant or breast-feeding

If you have heart desease

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 5 sprays 2 times a day directly to the scalp in the hair loss area

Using more than directed 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

STORAGE AND HANDLING SECTION

see hair loss pictures on side of this carton

Before use, read all information on the carton

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 aerosol 5% for men

in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical aerosol 5% for men provided more hair regrowth than minoxidil topical aerosol 2%

Store at 20 to 25°C (68 to 77°F). Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Water,Biotin, Rosemary Oil, Castor Oil, Panthenol, Niacinamide, Aloe Vera Extract, Ethanol, Glycerin

Questions

OTC - QUESTIONS SECTION

customerservice@avitapure.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01010202

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83299-020-012024-01-30C16284748780-11030e365-4fd1-111a-e063-dadaa90a10e20aa156ea-4b3d-5c9a-e063-6394a90a54c8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83299-02083299-020-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
20d1780d-e6ed-df9c-e063-6294a90a3ecd0aa156ea-4b3d-5c9a-e063-6394a90a54c82024-08-29WarningsExact identifier
spl set id: 0aa156ea-4b3d-5c9a-e063-6394a90a54c8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.