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  5. Label Information: Loesch Hair Regrowth Formula Unscented Topical Solution Extra-strength For Men

FDA Label for Loesch Hair Regrowth Formula Unscented Topical Solution Extra-strength For Men

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE IF
    6. OTC - ASK DOCTOR
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF YOU HAVE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. STORAGE AND HANDLING
    14. INACTIVE INGREDIENTS:
    15. QUESTIONS OR COMMENTS?
    16. DISTRIBUTED BY:
    17. PRINCIPAL DISPLAY PANEL

Loesch Hair Regrowth Formula Unscented Topical Solution Extra-strength For Men Product Label

The following document was submitted to the FDA by the labeler of this product Loesch Laboratory Consultant, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Minoxidil 5% w/v


Purpose



Hair Regrowth Treatment For Men


Use



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


Warnings



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


Do Not Use If



  • You are a woman.
  • 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 5% 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 5%.
  • In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%.

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

Extra-Strength Minoxidil 5% for Men

One Month Supply

60 ml (2.0 fl.oz.)

NDC: 25280-006-42

Carton.jpg Label.jpg


* Please review the disclaimer below.