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  5. Label Information: Mens Minoxidil Hair Growth System

FDA Label for Mens Minoxidil Hair Growth System

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. WARNINGS
    5. USE
    6. DO NOT USE IF
    7. OTC - ASK DOCTOR
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. STORAGE AND HANDLING
    16. PRINCIPAL DISPLAY PANEL - 60 ML BOTTLE LABEL

Mens Minoxidil Hair Growth System Product Label

The following document was submitted to the FDA by the labeler of this product Topiderm, 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.

Other



Drug Facts

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


Active Ingredient



Minoxidil 5% w/v


Purpose



Hair Regrowth for men


Warnings



For external use only. For use by men only.

Flammable: Keep away from fire or flame


Use



To regrow hair on the scalp


Do Not Use If



  • you are a woman
  • you have no family history of hair loss
  • your 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

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

MEN'S
Minoxidil Hair Regrowth

EXTRA STREGNTH
5% MINOXIDIL
TOPICAL SOLUTION, USP
HAIR REGROWTH TREATMENT

Reactivates Hair Follicles to Stimulate Regrowth
Clinically Proven to Help Regrow Hair
Topical Solution
Unscented

For Best Results:
Apply Directly to Scalp. Use Twice Daily

One Month Supply 60mL (2 fl oz)

Available Custom Branded
800.445.2595
[email protected]

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label - minoxidil 01

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label - minoxidil 01


* Please review the disclaimer below.