Growell Womens Hair Regrowth Treatment 2 Minoxidil Liquid
FDA Label NDC 84329-466

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apira Science, Inc. for the product Growell Womens Hair Regrowth Treatment 2 Minoxidil (NDC 84329-466). 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 drug facts, active ingredient, purpose, use, warnings:, do not use if:, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the top of the scalp

Warnings:

For external use only. 

Flammable:Keep away from fire or flame

Do Not Use If:

  • your degree of hair loss is different that than  shown on the side of this carton because this product may not work on 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

Ask A Doctor Before Use If You Have

heart disease

When Using This Product

  • do not apply on the 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. 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 everyone.

Stop Use And Ask A Doctor If

  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • scalp irritation or redness occurs
  • sudden, unexplained weight gain occurs
  • unwanted facial hair growth occurs
  • your hands or feet swell
  • you do not see hair regrowth in 4 months

Keep Out Of Reach Of Children.

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

Directions

  • apply one mL with dropper 2 times a daydirectly on to the scalp in the hair loss area
  • using more or more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth, or hair loss wil begin again

Other Information

  • See hair loss pictures on side of this carton
  • before use, reatd all information on carton and enclosed leaflet
  • keep the carton. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5 % minoxidil topical solution for men
  • in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: (19% of women reporting moderate hair regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

Call toll-free 1-(866)-982-7472

Visit our website at www.GroWellHair.com

Package Labeling:

Bottle2 (Bottle2)

Bottle2 (Bottle2)

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