Label: SOLUTION- minoxidil solution
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 27, 2017
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- Active Ingredient
- WarningsFor external use only.
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
- Ask a doctor before use if you have:
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
- Stop use and ask a doctor if:
- May be harmful if used when pregnant 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 18-49 years wiht 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 controlled room temperature 20o to 25oC (68o to 77oF). Keep tightly closed.
- Inactive Ingredients
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2173 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 0.02 g 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:0363-2173-02 1 in 1 PACKAGE 08/08/2014 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 08/08/2014 Labeler - Walgreens (008965063) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Ei LLC 105803274 manufacture(0363-2173) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 label(0363-2173)