Loesch Hair Regrowth Formula
FDA Label NDC 25280-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Loesch Laboratory Consultant, Inc. for the product Loesch Hair Regrowth Formula (NDC 25280-007). 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, otc - ask doctor, when using this product, stop use and ask a doctor if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair Regrowth Treatment

Use

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

Warnings

For external use only. Flammable: Keep away from fire or flame.

Do Not Use If

  • Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution 2% is not intended for frontal baldness or receding hairline.
  • You have no family history of hair loss.
  • You 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 or 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. Results may occur at 2 months with twice daily 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 everyone.

Stop Use And Ask A Doctor If You Have

  • 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.

Otc - Pregnancy Or Breast Feeding

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)

Directions

  • Apply one mL 2 times daily directly onto the scalp in the hair loss area.
  • Using more or more often will not improve results.
  • Continued use is necessary or hair loss will resume.

Other Information

  • See hair loss picture on the side of this carton.
  • Before use, read all information on carton and printed insert.
  • 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 Minoxidil Topical Solution 2%.
  • In clinical studies with mostly caucasian women aged 18-45 years with mild to no moderate degrees of hair loss, the following respone to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using Minoxidil Topical Solution 2% for 8 months. This compares with 7% of women reporting moderate hair regrowth and 33% reporting minimal regrowth after using the placebo, the liquid without minoxidil in it, for 8 months.

Storage And Handling

Store at 20-25C (68-77F). Keep tightly closed.

Inactive Ingredients:

Alcohol, Propylene Glycol, Purified water

Questions Or Comments?

1-800-237-7157

Distributed By:

Loesch Laboratory Consultants, Inc.

4311 South Dr., Houston

Texas 77053-4820, USA

800-231-7157

M-F 8 am - 5 pm CST

www.loeschlab.com

Principal Display Panel

Loesch® Hair Regrowth Formula

Regular-Strength Minoxidil 2% for Men and Women

One Month Supply

60 ml (2.0 fl.oz.)

NDC: 25280-007-42

Carton.jpg Label.jpg

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