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

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BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Women

BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Women


Active Ingredient

Minoxidil 2.0% w/v

Purpose

Hair regrowth treatment for men

Use

to regrow hair on the scalp

Warnings

For external use only
Flammable: keep away from fire or flame

Do not use if

  • your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you.
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • you hair loss is associated with childbirth
  • 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. you may need to use this product 2 times a day 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

  • 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 with dropper 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 to increase and keep your hair regrowth 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
  • in clinical studies with mostly white women aged 18-15 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using woman's minoxidil topical solution 2% for 8 months: 19% had moderate regrowth: 40% had minimal regrowth. This compares with 7% of women reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth).
  • 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 Women 2-60ml (65121-101-02)

Bosley Women Label

BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR WOMEN 
minoxidil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL20 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:65121-101-022 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(65121-101)

Revised: 2/2017
Document Id: 482e2384-ef37-01c7-e054-00144ff88e88
Set id: 91c962e1-afb1-49e3-9ed9-5e6fb7a21b11
Version: 4
Effective Time: 20170210
 
Pure Source, LLC