Label: BOSLEY MINOXIDIL TOPICAL SOLUTION 2 FOR WOMEN- minoxidil liquid
- NDC Code(s): 69113-462-00
- Packager: Scientific Hair Research, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 21, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Use
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Warnings
For external use only.
Flammable:keep away from fire or flame
Do not use if:
- your amount of hair loss is different than that shown on the side of this box because this product may not work for you.
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- your 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 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 all women.
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Directions
- prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
- apply one ml. (6 sprays) 2 times a daydirectly 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
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Other information
- see hair loss pictures on side of this box
- before use, read all information on carton and enclosed insert
- keep carton, it contains important information
- in clinical studies with mostly white women aged 18-45 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° to 25°C (68° to 77°F)
- Inactive Ingredients
- Questions or comments?
- Label
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INGREDIENTS AND APPEARANCE
BOSLEY MINOXIDIL TOPICAL SOLUTION 2 FOR WOMEN
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69113-462 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:69113-462-00 1 in 1 BOX 02/26/2024 1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078176 02/26/2024 Labeler - Scientific Hair Research, LLC (961897647)
