ETERNAL MINOXIDIL

Manufacturer
Miramar Cosmetic, Inc.
Effective date
2022-03-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:04:52

Label at a glance#

ProductETERNAL MINOXIDIL
Active ingredientMINOXIDIL
Label structure10 sections

Dosage and administration

• Apply one mL 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.

Storage and handling

• In clinical studies of mostly white men age 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution provided more hair regrowth than 2% minoxidil topical solution. • Store at USP controlled room temperature 20° to 25°C (68° to 77°F.)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5%w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment

Use

INDICATIONS & USAGE SECTION

To regrow hair on the scalp.

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from the fire or flame.

Do not use if: • your amount of 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.

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. 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.

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply one mL 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

STORAGE AND HANDLING SECTION

• In clinical studies of mostly white men age 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution provided more hair regrowth than 2% minoxidil topical solution.
• Store at USP controlled room temperature 20° to 25°C (68° to 77°F.)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water.

SPL UNCLASSIFIED SECTION

SPIRIT BEAUTY

ReHair

TOPICAL SOLUTION | UNSCENTED

MADE IN USA
with domestic and foreign parts

Distributed by: Worldwide Cosmetics Inc.
2019 NW 84TH AVE, DORAL, FL 33122

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MINOXIDIL-201MINOXIDIL-201

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79974-20179974-201-03, 79974-201-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
6151bfa2-6e64-4242-b87b-1ac61dccbb6331b9438a-ed6c-4ec6-a8bd-b1c4e78ef1412022-08-23WarningsExact identifier
spl set id: 31b9438a-ed6c-4ec6-a8bd-b1c4e78ef141

Reported adverse events (FAERS/openFDA)#

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