Label: BOSLEY MINOXIDIL TOPICAL SOLUTION 5 (FOR MEN)- minoxidil liquid
- NDC Code(s): 69113-483-00
- Packager: Scientific Hair Research, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 1, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Use
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Warnings
For external use only. For men 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 box or your hair loss is 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 medicines on the scalp
When using this product
- do not apply on other part of the body
- avoid contact with the eyes. in case of accidental contact, rinse eyes with large amount of cool tap water
- some people have experienced changes in hair colour and/or texture
- it takes time to regrow hair. Results may occur at 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.
- Directions
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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
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with Minoxidil Topical Solution 5% for men
- in clinical studies with mostly white men aged 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair regrowth than Minoxidil Topical Solution 2%
- store at controlled room temperature 20° to 25° (68° to 77°)
- Inactive Ingredients
- Questions or comments?
- Package Labelling:
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INGREDIENTS AND APPEARANCE
BOSLEY MINOXIDIL TOPICAL SOLUTION 5 (FOR MEN)
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69113-483 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:69113-483-00 1 in 1 BOX 05/06/2024 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 05/06/2024 Labeler - Scientific Hair Research, LLC (961897647)