BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR MEN- minoxidil liquid 
Pure Source, LLC

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BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men

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)

Bosley Men Label

BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR MEN 
minoxidil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65121-102-052 in 1 CARTON02/09/2017
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623908/15/2013
Labeler - Pure Source, LLC (080354456)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(65121-102)

Revised: 2/2017
Document Id: 482e2384-efa5-01c7-e054-00144ff88e88
Set id: 6882d0a7-1338-4cc3-a502-c3d8fed32c86
Version: 3
Effective Time: 20170210
 
Pure Source, LLC