Nizoral Hair Regrowth Treatment For Men Aerosol, Foam
FDA Label NDC 55505-237

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Nizoral Hair Regrowth Treatment For Men (NDC 55505-237). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use if, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Minoxidil USP 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men

Use

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

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. 5% minoxidil topical 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

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.

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

Other Information

  • hair growth has been shown in a clinical study of men (mostly white) aged 18 to 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 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]
  • 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

alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

Call toll-free 1-800-824-4894

Package Label.Principal Display Panel

NOT FOR DANDRUFF

Nizoral®

Hair Regrowth

Treatment For Men
MINOXIDIL TOPICAL AEROSOL 5%

REACTIVATES HAIR FOLLICLES
to stimulate regrowth

CLINICALLY PROVEN
to help regrow hair

UNSCENTED

EASY-TO-USE FOAM

NOT FOR USE BY WOMEN

THREE MONTH SUPPLY
CONTAINS: THREE ● 60 g(2.11 oz) CANS

P1062483

FOR BEST RESULTS
USE
TWICE
DAILY

APPLY DIRECTLY TO SCALP

Minoxidil Topical Aerosol, 5% (For Men) is for men who have a general thinning of hair on the top of the scalp (vertex only, as shown below). Not intended for frontal baldness or a receding hairline. Minoxidil Topical Aerosol, 5% (For Men) has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.

If men have more hair loss or hair loss in a place different than shown above, Minoxidil Topical Aerosol, 5% (For Men) may not work.

THIS PACKAGE CONTAINS
Three 60 g (2.11 oz) cans of Minoxidil Foam (For Men) (Three month supply)

DIRECTIONS FOR USE
See information leaflet with complete directions on how to use and obtain best results.

1: PREP HANDS WITH COLD WATER
Rinse your fingers in cold water and dry them. Note: foam will melt on contact with warm surfaces.

2: OPEN CHILD RESISTANT CAP
Be sure to align arrow on the cap with arrow on white ring. Tilt cap back and pull off.

3: DISPENSE VERTICALLY ONTO A COLD SURFACE
Hold the can straight upside down. If you hold the can at an angle, foam may not dispense properly. Press nozzle to dispense half a capful of foam onto cold surface (e.g. dish, or cold hands).

4: APPLY TO SCALP, NOT HAIR
Part your hair to expose hair loss area. Massage foam into scalp, not hair. Repeat until all hair loss areas have been covered.

5: CLOSE CAP AND WASH HANDS
Snap cap back into place. Be sure arrows do not line up, so cap remains child resistant. Wash hands and any surface thoroughly after use.

Distributed by: Kamer Laboratories, Inc.
Bridgewater, NJ 08807 USA
Made in India
© 2026 KRAMER LABORATORIES, INC.

Code: TS/DRUGS/58039/2020

Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling:
1.800.824.4894

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