Drug labels

Minoxidil

MINOXIDIL · Keranique · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
4af782f4-68d5-4338-a0a6-85d11a23ce98
ID
5d8ff259-bc22-4e95-8367-8cda4630eee6
Effective time
20260818
Version
7
SPL product data elements

Minoxidil Minoxidil MINOXIDIL MINOXIDIL BUTANE BUTYLATED HYDROXYTOLUENE CETYL ALCOHOL ANHYDROUS CITRIC ACID GLYCERIN ISOBUTANE LACTIC ACID POLYSORBATE 60 PROPANE WATER ALCOHOL STEARYL ALCOHOL

SPL unclassified section
Drug Facts
Active ingredient
Active ingredient Minoxidil 5% w/w (without propellant)
Purpose
Purpose Hair regrowth treatment for women
Indications and usage
Use to regrow hair on the top of the scalp (see pictures on side of this carton)
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.

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 doctor
Ask a doctor before use if you have heart disease
When using

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

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.
Keep out of reach of children
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.
Dosage and administration

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

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
Package label principal display panel

Principal display panel *Compare to active ingredient in Women's Rogaine® Minoxidil Topical Aerosol, 5% Hair Regrowth Treatment For Women Clinically proven to help regrow hair Reactivates hair follicles to stimulate regrowth Unscented Once-a Day Foam for women TWO MONTH SUPPLY 60 g (2.11OZ CAN *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Women's Rogaine®. Distributed by: Profectus Beauty, LLC., 111 Town Square Pl, Suite 1130 Jersey City, NJ 07310

Package label Keranique Hair Regrowth Treatment for women Minoxidil 5%

Harmonized identifiers (openFDA)
Application number
ANDA208092
Brand name
Minoxidil
Generic name
MINOXIDIL
Manufacturer name
Keranique
Product NDC
70550-116
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
MINOXIDIL
RxCUI
645146
SPL ID
5d8ff259-bc22-4e95-8367-8cda4630eee6
SPL set ID
4af782f4-68d5-4338-a0a6-85d11a23ce98
Package NDC
70550-116-02, 70550-116-20
Is original packager
true
Upc
0885418012797
Nui
N0000175379, N0000175564
Pharm class pe
Arteriolar Vasodilation [PE]
Pharm class epc
Arteriolar Vasodilator [EPC]
UNII
5965120SH1
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.