Minoxidil For Women Aerosol, Foam
FDA Label NDC 70000-0753

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Minoxidil For Women (NDC 70000-0753). 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.

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.

Otc - 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.

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 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 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)

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Women’s Rogaine®.

CardinalHealth

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
 Essential to Care™ since 1979
Made in India

Code: TS/DRUGS/58039/2020

CIN 6103956     REV. 02/26

Principal Display Panel - One 60 G Can Carton

LEADER™

NDC 70000-0753-1
For Women
Minoxidil
Topical
Aerosol, 5%
Hair Regrowth Treatment

Hair Regrowth
Treatment for Women

 Reactivates
Hair Follicles
to Stimulate
Regrowth

Clinically Proven
to Regrow Hair

Once-a-Day
Foam For Women


COMPARE TO
WOMEN'S
ROGAINE®
active ingredient*

100% Money
Back Guarantee

Unscented

2 MONTH SUPPLY
1-60 g (2.11 OZ) CAN

  

Principal Display Panel (One 60 g Can Carton)

Principal Display Panel (One 60 g Can Carton)

* Please review the disclaimer below.