Regoxidine

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/w (without propellant)

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for women

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (see pictures on side of this carton)

Warnings

WARNINGS SECTION

For external use only.

Extremely Flammable

SPL UNCLASSIFIED SECTION

Avoid fire, flame, or smoking during and immediately following application.

Do not use if

OTC - DO NOT USE SECTION

• your degree of hair loss is different than that shown on 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 and 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

OTC - WHEN USING SECTION

• do not use more than directed
• 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 3 months with once-daily use. For some women, you may need to use this product once a day for at least 6 months before you see results.
• the amount of hair regrowth is different for each person. This product will not work for all women.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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 6 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• see enclosed leaflet for complete directions on how to use
• apply half a capful once daily directly to the scalp in the hair loss area
• massage into scalp with fingers, then wash hands well
• 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

• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton. It contains important information.
• store at controlled room temperature 20° to 25°C (68° to 77°F)
• contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

• Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Innovus Pharmaceuticals, Inc.
Englewood, CO 80112

PRINCIPAL DISPLAY PANEL - Two 60 g Can Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57483-540-31

C^•rcle_™

Regoxidine^®

Minoxidil Topical
Aerosol, 5%
(For Women)

Hair Regrowth
Treatment

ONCE-A-DAY
FOAM
for Women

Unscented

Reactivates Hair Follicles to
Stimulate Regrowth

Clinically Proven to Regrow Hair

#1 Dermatologist Recommended Active Ingredient^†
*Compare to the active ingredient of Women's Rogaine^®

FOUR MONTH SUPPLY
TWO 2.11 OZ (60 g) CANS

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

• Regoxidine (For Women)
• Minoxidil
• butylated hydroxytoluene
• cetyl alcohol
• anhydrous citric acid
• ALCOHOL
• isobutane
• LACTIC ACID, UNSPECIFIED FORM
• BUTANE
• polysorbate 60
• propane
• WATER
• stearyl alcohol

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

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.

Product history page 1 of 3 · 86 observed states.

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.

Reported adverse events (FAERS/openFDA)#

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