Minoxidil 5% (for Women) Aerosol, Foam
FDA Label NDC 58602-607

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Minoxidil 5% (for Women) (NDC 58602-607). 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, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Minoxidil USP 5% w/w (without propellant)

Purpose

Hair regrowth treatment for women

Use

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

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 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

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

Otc - Pregnancy Or Breast Feeding

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

Directions

  • see enclosed booklet 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

  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet
  • keep the carton. It contains important information.
  • Store at 20°C to 25°C (68°F 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 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


Distributed by:
AUROHEALTH LLC.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India
Code: TS/DRUGS/58039/2020

Principal Display Panel - One 60 G Can Label

AUROHEALTH

NDC 58602-607-01


Minoxidil
Topical
Aerosol 5%
(FOR WOMEN)

HAIR REGROWTH
TREATMENT

REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH

CLINICALLY PROVEN
TO REGROW HAIR

Once-a-Day
Foam For Women

UNSCENTED

Two Month Supply
One 60 g (2.11 OZ) Can

Fig (Minoxid Fig7)

Fig (Minoxid Fig7)

Principal Display Panel - One 60 G Can Carton

AUROHEALTH

NDC 58602-607-01

*Compare to the active ingredient
of Women's Rogaine®

Minoxidil Topical
Aerosol 5% (FOR WOMEN)

HAIR REGROWTH TREATMENT

REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH

Once-a-Day
Foam For Women

CLINICALLY PROVEN TO REGROW HAIR


UNSCENTED

TWO MONTH SUPPLY
ONE 60 g (2.11 OZ) CAN

 

Fig (Minoxid Fig8)

Fig (Minoxid Fig8)

* Please review the disclaimer below.