Label: ESALON HAIR REGROWTH TREATMENT WOMENS MINOXIDIL- minoxidil solution
- NDC Code(s): 84856-604-00
- Packager: ESALON.COM, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 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 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
- 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, irritated or painful
- you use other medicines 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.
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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 1 mL with sprayer (6 sprays) 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 to increase and keepyour hair regrowth, or hair loss will begin again
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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 age 18-45 years with mild to moderate degrees of hair loss, the follwing response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using women'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?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ESALON HAIR REGROWTH TREATMENT WOMENS MINOXIDIL
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84856-604 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:84856-604-00 1 in 1 BOX 10/16/2024 1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078176 10/16/2024 Labeler - ESALON.COM, LLC (929649395)
