BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR MEN- minoxidil liquid

BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men by

Drug Labeling and Warnings

BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR MEN 
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-102-05	2 in 1 CARTON	02/09/2017
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	08/15/2013

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-102)