Label: BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR MEN- minoxidil liquid
- NDC Code(s): 65121-102-05
- Packager: Pure Source, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 10, 2017
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- BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men
- Active Ingredient
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.
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
- 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
- Questions or comments?
- 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
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)