Label: MINOXIDIL TOPICAL SOLUTION, 5%- minoxidil solution solution
- NDC Code(s): 51672-2151-4, 51672-2151-9
- Packager: Sun Pharmaceutical Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 4, 2026
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only. For use by men only.
Flammable:Keep away from fire or flame
Do not use if
- you are a woman
- your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- 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. Results may occur at 2 months with twice a day usage. For some men, 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 men.
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Directions
- apply one mL with dropper 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 keep your hair regrowth, or hair loss will begin again
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.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
- In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
- store at controlled room temperature 20º to 25º C (68º to 77º F)
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Questions?
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
MINOXIDIL TOPICAL SOLUTION, 5%
minoxidil solution solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2151-4 1 in 1 CARTON 08/01/2025 1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:51672-2151-9 3 in 1 CARTON 08/01/2025 2 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217998 08/01/2025 Labeler - Sun Pharmaceutical Industries, Inc. (146974886) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 manufacture(51672-2151)
