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berkley and jensen minoxidil

minoxidil · berkley and jensen minoxidil is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by BJWC.

Type
Over the counter
Drug class
Arteriolar Vasodilator
Route
Topical
Manufacturers
1

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

Drug facts

Generic name
minoxidil
Active ingredients
Minoxidil
Dosage forms
Aerosol, foam
Label holder
BJWC
FDA application
ANDA091344
Label updated
04/29/2025

Active ingredients

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men

Uses

To regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

Directions

  • Apply half a capful 2 times a day to the scalp in the hair loss area
  • Massage into scalp with fingers, then wash hands well
  • See enclosed leaflet for complete directions on how to use
  • 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

For external use only. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. Do not use if

  • You are a woman
  • Your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol, 5% (Foam) 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, 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 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. This product will not work for all men. 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do not use

If

  • You are a woman
  • Your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol, 5% (Foam) 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, infected, irritated, or painful
  • You use other medicines on the scalp

Ask a doctor before use

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. This product will not work for all men.

Stop use and ask a doctor

  • 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

Pregnancy or breastfeeding

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Other information

  • Hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
  • See hair loss pictures on side of this carton
  • Before use, read all information on package and enclosed leaflet
  • Keep the package. It contains important information.
  • Store at controlled room temperature 20-25°C (68-77°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

Butane, butylated hydroxytoluene, cetyl alcohol, citric acid, dehydrated alcohol, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

1-800-BJS-CLUB

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Aerosol, foam5 g/100gtopical1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 44,659 reports that list minoxidil, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Adverse drug reaction8,585
  • Drug ineffective7,760
  • Alopecia3,801
  • Application site pruritus2,926
  • Off label use2,275
  • Overdose1,461
  • Application site irritation1,420
  • Application site pain1,413
  • Hair texture abnormal1,409
  • Headache1,342

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • BJWCShown hereANDA091344 · Label 04/29/2025 · NDC 68391-294Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

berkley and jensen minoxidil: common questions

What is berkley and jensen minoxidil used for?
to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Is berkley and jensen minoxidil a prescription drug?
No. berkley and jensen minoxidil is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as berkley and jensen minoxidil?
Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil for Women, Minoxidil.
Who makes berkley and jensen minoxidil?
BJWC lists berkley and jensen minoxidil with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/29/2025 · Label text is shown as published by the manufacturer. Not medical advice