Womens Minoxidil Liquid
FDA Label NDC 51326-161

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Womens Minoxidil (NDC 51326-161). 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 other, active ingredient, purpose, warnings, use, do not use if, otc - ask doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By: Topiderm Inc., 5200 New Horizions Blvd. N. Amityville, NY 11701

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair Regrowth for women

Warnings

For external use only.

Flammable: Keep away from fire or flame

Use

To regrow hair on the scalp

Do Not Use If

  • 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

Otc - Ask Doctor

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

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 of redness occurs
  • unwanted facial hair growth occurs

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. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply one mL 2 times a day directly onto the scalp in the hair loss area

  • see enclosed leaflet for complete Directions for Use
  • using more or more often will not improve result
  • continued use is necessary, or hair loss will begin again

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions?

Call Topiderm at 800-445-2595 or reach us on the internet at topiderm.com

Storage And Handling

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F)

Principal Display Panel - 60 Ml Bottle Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

WOMEN'S
Minoxidil Hair Regrowth

2% MINOXIDIL TOPICAL SOLUTION, USP
HAIR REGROWTH TREATMENT

Unscented

Clinically proven to help regrow hair

Reactivates hair follicles to
stimulate regrowth

Topical Solution

One Month Supply 60 mL (2 fl oz)

Available Custom Branded
800.445.2595
[email protected]

Principal Display Panel (60 mL Bottle Label)

Principal Display Panel (60 mL Bottle Label)

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