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OTC products · Product label record

Minoxidil drug information

MINOXIDIL
Keranique · TOPICAL

Product NDC: 70550-116

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameMINOXIDIL
Labeler / manufacturerKeranique
RouteTOPICAL
Drug classArteriolar Vasodilator
Product NDC70550-116
Label effective date2026-08-18

Official product label reference

Minoxidil — Keranique

This page contains 15 source sections for MINOXIDIL, topical route. Label set 4af782f4-68d5-4338-a0a6-85d11a23ce98, version 7.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purpose Hair regrowth treatment for women
Dosage and administration — label text
Directions 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
Warnings
Warnings For external use only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. 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 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 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 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 May be harmful if used when pregnant or breast-feeding. Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Unclassified section
Drug Facts
Active ingredient
Active ingredient Minoxidil 5% w/w (without propellant)
Do not use
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 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
Ask a doctor before use if you have heart disease
While using this medicine
When using this product 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.
When to stop use and seek help
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 6 months
Pregnancy or breast feeding
May be harmful if used when pregnant or breast-feeding.
Child safety
Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other safety information
Other information 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 20º to 25ºC (68º to 77ºF) contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperature above 120ºF (49ºC).
Inactive ingredient
Inactive ingredients butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol
Questions
Questions? Call toll free 1 -888-237-4131

Official sources and product identifiers

Substances listed: MINOXIDIL

RxNorm identifiers: 645146

Package NDC codes

70550-116-02, 70550-116-20

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.