Label: MDHAIR HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution
- NDC Code(s): 71804-711-02
- Packager: MDalgorithms, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 18, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
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DO NOT USE
• your amount 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, infected, irritated, or painful • you use other medicines on the scalp
- ASK DOCTOR
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WHEN USING
• 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. Results may occur at 2 months with twice a day usage. For some women, 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 women.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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 of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• store at USP controlled room temperature 20º to 25ºC (68º to 77ºF)
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MDHAIR HAIR REGROWTH TREATMENT FOR WOMEN
minoxidil 2% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71804-711 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71804-711-02 1 in 1 BOX 06/01/2021 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 06/01/2021 Labeler - MDalgorithms, Inc (080479826) Establishment Name Address ID/FEI Business Operations Pure Source, LLC 080354456 manufacture(71804-711)