Label: MINOXIDIL aerosol, foam
- NDC Code(s): 59726-151-60, 59726-151-70
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 3, 2024
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
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Warnings
For external use only. For use by men only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.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. Minoxidil topical Aerosol, 5% (Foam) 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 half a capful 2 times a day to the scalp in the hair loss area
- massage into scalp with fingers, then wash hands well
- see enclosed leaflet for complete directions on how to use
- using more or more often will not improve results
- continued use is necessary to increase and keep your regrowth, or hair loss will begin again
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Other information
- hair regrowth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 month
- 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
- store at controlled room temperature 20º to 25º C (68º to 77º F)
- contents under pressure. Do not puncture or incinerate container.
- Do not expose to heat or store at room temperatures above 120º F (49º C)
- Inactive ingredients
- Questions?
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Principal display panel
†Compare to the active ingredient in Men's Rogaine®
men's minoxidil Topical aerosol, 5%,
hair regrowth treatment
easy-to-use foam
- Reactivates hair follicles to stimulate regrowth
- Clinically proven to help regrow hair
- unscented
not for use by women
g (oz) can
Read and keep carton and information leaflet for full product information.
†This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Rogaine®.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
- Package label
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INGREDIENTS AND APPEARANCE
MINOXIDIL
minoxidil aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-151 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 g Inactive Ingredients Ingredient Name Strength BUTANE (UNII: 6LV4FOR43R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) ISOBUTANE (UNII: BXR49TP611) LACTIC ACID (UNII: 33X04XA5AT) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPANE (UNII: T75W9911L6) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-151-60 1 in 1 PACKAGE 07/01/2024 1 60 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:59726-151-70 3 in 1 PACKAGE 07/01/2024 2 60 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208092 07/01/2024 Labeler - P & L Development, LLC (800014821)