Label: DANIEL ALAIN HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution
- NDC Code(s): 82545-001-01
- Packager: Daniel Alain, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 4, 2022
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- ACTIVE INGREDIENT
DO NOT USE
Do not use if
- Your amount of hair loss is different than that shown on 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 or children.
- Your scalp is red, inflammed, infected, irritated, or painful
- You use other medicines on your scalp
- ASK DOCTOR
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 regrow is different for each person. This product will not work for all women..
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- 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 of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solutions was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate 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 68 o - 77 oF (20 o - 25 oC).
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DANIEL ALAIN HAIR REGROWTH TREATMENT FOR WOMEN
minoxidil 2% solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82545-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82545-001-01 1 in 1 BOX 02/04/2022 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 ANDA078176 02/04/2022 Labeler - Daniel Alain, Inc (010990313)