5% Minoxidil Spray

Manufacturer
Consilii LLC
Effective date
2023-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:24:45

Label at a glance#

Product5% Minoxidil Spray.
Active ingredientMINOXIDIL
Label structure14 sections

Dosage and administration

Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed Spray directly on top of the scalp in the area to be treated Discontinuing use may result in hair loss

Storage and handling

Before use, read all information on the carton Store at controlled room temperature 20 to 25 C (68 to 77°F)

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

Warnings

WARNINGS SECTION

For external use only

Keep away from fire and flame

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

You have no family history of hair loss,hair loss is sudden and/or patchy

you are under 18 years of age.Do not use it on babies and children

When Using

OTC - WHEN USING SECTION

Do not apply on other parts of the body

void contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water

It takes time to regrow hair. You may need to use this product 2 times a day for a least 4 months before you see results, The amount of hair regrowth is different for each person

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

Ask Doctor

OTC - ASK DOCTOR SECTION

When Pregnant or breast-feeding

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed

Spray directly on top of the scalp in the area to be treated

Discontinuing use may result in hair loss

Other information

STORAGE AND HANDLING SECTION

Before use, read all information on the carton

Store at controlled room temperature 20 to 25 C (68 to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Water,Propylene Glycol,Ethyl Alcohol,Potassium Sorbate,GABA

Questions

OTC - QUESTIONS SECTION

Tomumcs@gmail.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83299-014-012024-01-30C16284748780-11030e365-451b-111a-e063-dadaa90a10e2071b9257-9e7d-e71c-e063-6294a90ae837

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83299-01483299-014-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
20d17107-8878-e53c-e063-6294a90a58a7071b9257-9e7d-e71c-e063-6294a90ae8372024-08-29WarningsExact identifier
spl set id: 071b9257-9e7d-e71c-e063-6294a90ae837

Reported adverse events (FAERS/openFDA)#

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