FDA Label for Bosley Professional Strength Hair Regrowth Treatment Regular Strength For Men

View Indications, Usage & Precautions

Bosley Professional Strength Hair Regrowth Treatment Regular Strength For Men Product Label

The following document was submitted to the FDA by the labeler of this product Pure Source, Llc. 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.

Bosley Professional Strength Hair Regrowth Treatment Regular Strength For Men





Active Ingredient



Minoxidil 5.0% w/v


Purpose



Hair regrowth treatment for men


Use



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


Warnings



For external use 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 on the front of the scalp. 5% Minoxidil Topical Solution is not intended for frontal baldness or receding hairline.
  • 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 and children.
  • your scalp is red, inflamed, infected, irritated, or painful
  • you use other medications on the scalp.

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.
  • It takes time to regrow hair. Result may occur all 2 months with twice a day 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 all men.

Stop Use And Ask A Doctor If



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

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 right away.


Directions



  • apply one ML 2 times a day 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 begin again

Other Information



  • see hair loss pictures on side of this carton
  • before use read all information on carton and enclosed leaflet
  • keep the carton, it contains important information
  • hair growth 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 white men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% provided more hair regrowth than Minoxidil Topical Solutions 2%
  • store at controlled room temperature 20 degree to 25 degree C (68 degree to 77 degree F)

Inactive Ingredients



alcohol 30% v/v, propylene glycol 50% v/v, purified water


Questions Or Comments?



questions: call your health professional or Bosley at 1(800)BOSLEY1


Bosley Professional Strength Hair Regrowth Treatment Regular Strength For Men 2-60Ml (65121-102-05)




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