Label: MINOXIDIL solution
- NDC Code(s): 0363-9972-06
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 2, 2023
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
- Purpose
- Use
-
Warnings
For external use only
Flammable: Keep away from fire or flameDo 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, infected, 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.
- Directions
-
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 to 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 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
-
Principal display panel
Compare to the active ingredient in Women's Rogaine®††
Minoxidil Topical Solution, USP 2%
HAIR REGROWTH TREATMENT
For Women Topical Solution Unscented
- Reactivates hair follicles to stimulate regrowth
- Clinically proven to help regrow hair
- For best results, apply directly to scalp twice daily
mL (FL OZ) BOTTLES
††This product is not affiliated with, manufactured by, or produces by the makers or owners of Rogaine®.
DISTRIBUTED BY: WALGREEN CO.
200 WILCOT RD., DEERFIELD, IL 60015
- Package label
-
INGREDIENTS AND APPEARANCE
MINOXIDIL
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9972 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 ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9972-06 3 in 1 CARTON 10/14/2022 02/28/2025 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 ANDA074588 10/14/2022 02/28/2025 Labeler - Walgreens (008965063)
