Label: BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR WOMEN- minoxidil liquid
- NDC Code(s): 65121-101-02
- Packager: Pure Source, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 10, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Women
- Active Ingredient
- Use
-
Warnings
For external use only
Flammable: keep away from fire or flameDo 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.
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.
- your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you.
- Directions
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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
- Questions or comments?
- BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Women 2-60ml (65121-101-02)
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INGREDIENTS AND APPEARANCE
BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR WOMEN
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65121-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 20 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:65121-101-02 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(65121-101)